DFS 070614Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521080744), received between Sep 18, 2019 and Jul 7, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, IN AN OPEN HERNIA PROCEDURE, DURING MESH FIXATION, THE LEVER COULD NOT BE SQUEEZED. SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO CONTINUE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17278434 ↗
• MalfunctionOct 16, 2019Entrapment of Device; Failure to Form Staple; Entrapment of Device; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN OPEN HERNIA PROCEDURE, WHEN FIRING, STAPLES PARTIALLY DEPLOYED BUT WAS STUCK IN THE END OF THE STAPLER AND WAS CAUGHT ON TISSUE. STAPLES THAT WERE DEPLOYED DID NOT FORM PROPERLY. ANOTHER STAPLER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9197886 ↗
• MalfunctionSep 20, 2019Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING AN INGUINAL HERNIA REPAIR, WHEN ATTACHING THE HERNIA MESH, THE LEVER CAN BE SQUEEZED, THE INITIAL STAPLES FIRED CORRECTLY, THEN THE LAST ONE JAMMED. THE STAPLE WAS HALF IN AND HALF OUT THAT WAS STUCK AT THE END OF THE STAPLER THAT WAS CAUGHT ON THE TISSUE. NO ADDITIONAL TREATMENT REQUIRED. IT WAS THE FINAL STAPLE BEING FIRED FOR REINFORCEMENT. THE SURGEON THEN DECIDED NO OTHER STAPLES WERE REQUIRED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9098451 ↗
• MalfunctionSep 18, 2019Break; Failure to Form Staple; Break; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A INGUINAL HERNIA REPAIR OPEN PROCEDURE, WHEN ATTACHING HERNIA MESH, THE SECOND FIRING STAPLE NEEDED TO BE REMOVED AS THE STAPLER WAS NOT FIRING CORRECTLY AND THE RELOAD WAS COMING OUT WITH THE STAPLES. THE CASE WAS FINISHED WITH SUTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9081537 ↗