What Can Go Wrong With a Surgical Stapler?

Surgeons use internal surgical staplers to cut, seal, divide, or reconnect tissue during procedures involving the gastrointestinal tract, lungs, blood vessels, and other organs. They are also used to create anastomoses, which are surgical connections between sections of tissue.

The staples must form correctly and create a secure staple line. A failure can involve:

• An incomplete staple line
• Missing or malformed staples
• Failure to fire
• Partial firing
• Unexpected device lockout
• Improper staple formation
• Separation or opening of a staple line

The FDA has associated surgical stapler problems with bleeding, tissue damage, anastomotic leaks, infection, sepsis, additional surgery, and death.

These failures are distinct from the broader category of medical device and healthcare product defects because the condition of the tissue, the specific stapler and reload used, device performance, surgical technique, and postoperative response may all need to be evaluated.

Recent Surgical Stapler Recalls Show the Potential Consequences

In 2026, the FDA classified a recall involving Intuitive Surgical 8mm SureForm 30 Gray Reloads as Class I, its most serious recall classification. Intuitive reported that certain reloads could produce incomplete staple lines when used on blood vessels. According to the FDA, four serious injuries and one death had been associated with the issue as of February 23, 2026.

The FDA explained that an incomplete staple line could leave the contents of a cut blood vessel exposed, causing bleeding severe enough to require conversion to open surgery.

The recall remained listed as open and classified in the FDA recall database as of July 2026.

The FDA also classified an Ethicon Endopath Echelon vascular stapler reload correction as Class I after reports of inadvertent device lockout during procedures. Potential consequences included surgical delay, hemorrhage, hemorrhagic shock, conversion to open surgery, and death. The FDA reported one injury and one death associated with that issue.

A recall does not establish that every covered stapler or reload was defective or caused a particular patient’s injury. It can, however, identify a specific failure mode that warrants investigation when a patient experiences an otherwise unexplained surgical complication.

How Can Surgical Stapler Failure Cause Internal Bleeding?

When a stapler is used on a blood vessel or highly vascular tissue, the staple line must control bleeding after the tissue is divided.

If staples fail to form correctly or part of the staple line remains open, a patient can experience significant internal hemorrhage.

Depending on the location and severity, the consequences may include:

• Rapid blood loss
• Falling blood pressure
• Hemorrhagic shock
• Blood transfusions
• Emergency reoperation
• Conversion to open surgery
• Organ damage from inadequate blood flow
• Death

Severe bleeding can also contribute to catastrophic internal organ damage or organ failure, particularly when hemorrhage is not controlled quickly.

How Can Stapler Failure Cause an Anastomotic Leak?

An anastomotic leak occurs when a surgically created connection between sections of tissue does not remain sealed.

A stapler malfunction may contribute to a leak when staples fail to form completely, part of the staple line separates, or the device fails to adequately close the tissue.

Depending on the location of the surgery, intestinal contents, bacteria, digestive fluids, or other material can leak into surrounding tissues or the abdominal cavity.

Patients may require:

• Drainage procedures
• IV antibiotics
• Emergency or revision surgery
• Removal of damaged tissue
• An ostomy
• Extended hospitalization or intensive care

The critical question is not simply whether a leak occurred. An investigation must determine why the staple line failed and what happened after the complication developed.

When a Surgical Leak Leads to Sepsis

A leak can allow bacteria and contaminated material to enter areas of the body that should remain sterile. Infection may progress to an abscess, peritonitis, bloodstream infection, sepsis, septic shock, or organ failure.

A stapler malfunction may explain how the contamination began. The postoperative medical response presents a separate question.

Doctors and hospitals may need to recognize signs of bleeding, leakage, infection, or deterioration and respond with appropriate testing and treatment. When providers fail to respond appropriately to a developing complication, the investigation may also involve failure to treat or other forms of medical malpractice.

That distinction matters because the device manufacturer and healthcare providers may present separate liability issues.

Was the Stapler Defective, Was There a Surgical Error, or Both?

A catastrophic complication after stapler use does not automatically establish either a product defect or medical malpractice.

The evidence may point to one or several potential failures, including:

• Defective stapler or reload design
• Manufacturing defects
• Inadequate warnings or instructions
• Failure of the device to fire correctly
• Malformed or missing staples
• Incomplete staple-line formation
• Improper selection of the stapler or reload
• Incorrect staple size for the tissue
• Improper placement or deployment
• Failure to inspect the staple line
• Failure to control bleeding
• Failure to recognize a developing leak
• Delayed diagnosis or treatment of infection or sepsis

A product liability claim may examine the stapler’s design, manufacture, labeling, and performance. A medical negligence claim may focus on how the device was selected and used, how the staple line was evaluated, and how providers responded when the patient’s condition worsened.

Some cases require both investigations.

What Evidence Matters After a Suspected Surgical Stapler Malfunction?

Identifying exactly which stapler and reload were used can be critical.

A recall or adverse-event report may apply to only a particular model, part number, reload, lot, or production period. The operative report alone may not contain all of that information.

Relevant evidence may include:

• Operative reports
• Surgical videos or robotic procedure recordings, when available
• Nursing and postoperative monitoring records
• Imaging showing bleeding, leakage, or infection
• Laboratory results
• Records from revision or emergency surgery
• Manufacturer and model information
• Stapler reload or cartridge records
• Lot numbers
• Unique Device Identifiers
• Hospital purchasing and inventory records
• Device malfunction or incident reports
• FDA recall records
• Manufacturer communications
• Pathology findings
• The stapler, reload, cartridge, or other components, if preserved

The device itself can be particularly important. Inspection may help determine whether a mechanical problem occurred and whether the failure is consistent with other documented problems involving the same product.

Why These Cases Require More Than a Review of the Medical Chart

A medical chart can show that a patient hemorrhaged, developed a leak, became septic, or underwent emergency surgery. It may not explain why.

A meaningful investigation may require reconstructing the procedure, identifying the exact device and reload, reviewing imaging and subsequent surgeries, examining FDA and manufacturer records, and determining whether the product remained available for inspection.

Medical-device engineers may be needed to evaluate how the stapler functioned. Surgical experts may evaluate device selection, deployment, staple-line inspection, and the response to complications.

That combined investigation can distinguish an unavoidable surgical complication from a defective product, preventable medical error, or both.

When Surgical Stapler Failure Results in Wrongful Death

Uncontrolled hemorrhage, sepsis, organ failure, or complications from emergency revision surgery can become fatal.

When a patient dies following a suspected stapler malfunction, the evidence may support a wrongful death claim, depending on what the investigation establishes and the law that applies.

The analysis may include the device’s design and manufacturing history, prior adverse-event reports, recall information, how the stapler performed during the operation, whether the staple line was adequately evaluated, and whether postoperative complications were recognized and treated appropriately.

If you or a family member suffered catastrophic internal bleeding, an anastomotic leak, sepsis, emergency revision surgery, organ failure, or death following a suspected surgical stapler malfunction, contact McEldrew Purtell for a free consultation.

Our attorneys can investigate whether a defective surgical device, medical negligence, or a combination of failures contributed to the injury. We also welcome referrals from attorneys evaluating catastrophic surgical stapler, medical-device, and wrongful-death matters.