Surgical Stapler Lawsuits: Malfunction Claims and Hidden Adverse Event Reporting

What These Claims Involve

Surgical staplers close tissue during operations, replacing hand suturing in many procedures. When one malfunctions the consequence is immediate and serious, since the tissue it was closing may leak or bleed internally.

Alleged failure modes include failing to fire, firing incompletely so staples do not form properly, misfiring, and locking mid-procedure. Reported consequences include internal bleeding, leakage of intestinal contents, sepsis, extended surgery and further operations.

The Reporting Issue

A significant issue in this litigation concerned how adverse events were reported. A regulatory programme permitted certain well-known device malfunctions to be reported in periodic summary form rather than as individual public reports.

The effect was that a large volume of stapler malfunctions did not appear in the publicly searchable adverse event database that surgeons and hospitals consult. When the programme was ended and historic reports released, the reported volume was far larger than the public record had suggested.

That matters legally because knowledge is central to failure to warn claims. If a manufacturer held malfunction data that was not visible to the clinicians choosing devices, the adequacy of the warnings provided is squarely in issue.

What Patients Should Request

Obtain the complete operative report, which should identify devices used, and the implant or device log recording manufacturer, model and lot. Hospitals retain these and patients are entitled to them.

Records of any return to theatre, imaging showing leakage or collection, and the treatment of any resulting infection establish both the injury and its connection to the procedure.