PERMAFIX 0113119Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741016714), received between Jan 14, 2020 and May 19, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 19, 2022Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, THE BARD/DAVOL PERMAFIX ENHANCED FIXATION DEVICE WAS USED TO FIXATE AN UNKNOWN MESH. AS REPORTED, TWO FASTENERS SUCCESSFULLY FIXATED THE MESH AND THE THIRD AND SUBSEQUENT FASTENERS DID NOT PIERCE THE TISSUE. THE DEVICE STOPPED FIRING AFTER FIRING SEVERAL FASTENERS. THE FASTENERS THAT DID NOT FIXATE THE MESH WERE REMOVED FROM THE PATIENT AND THERE WERE NO BROKEN FASTENERS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14434367 ↗
• MalfunctionMar 4, 2022Failure to Form Staple; Failure to Form Staple

  AS REPORTED, THE BARD/DAVOL PERMAFIX FIXATION DEVICE WAS USED TO FIXATE AN UNSPECIFIED MESH USING ADEQUATE COUNTER-PRESSURE IN A LAPAROSCOPIC PROCEDURE ON (B)(6) 2022. AS REPORTED, A FEW FASTENERS SUCCESSFULLY FIXATED THE MESH, AFTER WHICH THE FASTENERS DID NOT ADEQUATELY FIXATE THE MESH. AS REPORTED, THE LOOSE FASTENERS WERE REMOVED FROM THE PATIENT¿S BODY. AS REPORTED, THE DEVICE WAS DRY-FIRED AND THE ISSUE OCCURRED AGAIN. THE PROCEDURE WAS COMPLETED USING ANOTHER PERMAFIX DEVICE AND THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13670569 ↗
• MalfunctionApr 1, 2020Incorrect, Inadequate or Imprecise Result or Readings; Failure to Fire; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC INGUINAL TAPP PROCEDURE, THE PERMAFIX FAILED TO FIRE AFTER THE FIRST FASTENER WAS DEPLOYED. THE FASTENER THAT WAS DEPLOYED DID NOT PROVIDE ADEQUATE FIXATION, HOWEVER THERE WERE NO BROKEN, LOOSE OR PROUD FASTENERS IN THE BODY AS A RESULT OF THE PROBLEM. THERE WAS A PROLONGATION OF THE CASE WHILE THE SURGEON OBTAINED ANOTHER PERMAFIX DEVICE TO COMPLETE THE PROCEDURE. AS REPORTED, THERE WAS NO INJURY OR IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9914237 ↗
• MalfunctionJan 14, 2020Incorrect, Inadequate or Imprecise Result or Readings; Insufficient Device Problem Information; Incorrect, Inadequate or Imprecise Result or Readings; Insufficient Device Problem Information

  IT WAS REPORTED THAT WHILE FIXATING A BARD/DAVOL SOFT MESH DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE FASTENERS IN THE PERMAFIX FIXATION DEVICE WERE COMING OUT AND WERE WOULD NOT FIXATE THE TISSUE / HOLD THE MESH. THIS WAS TRIED WITH 5-6 FASTENERS AND OCCURRED REPEATEDLY. A NEW FIXATION DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY AS A RESULT OF THE PROBLEM EXPERIENCED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9588852 ↗