OPTIFIX 0113315Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741136559), received between Oct 29, 2020 and Mar 5, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2025Use of Device Problem; Use of Device Problem

  AS REPORTED, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR, OPTIFIX AT FIXATION DEVICE WHICH HAD A LABELED EXPIRATION DATE OF 28-NOV-2024 WAS IMPLANTED IN THE PATIENT ON (B)(6) 2025. IT WAS REPORTED THAT NO MALFUNCTION OF THE DEVICE OTHER THAN IT WAS EXPIRED. THERE WAS NO REPORTED PATIENT INJURY, CHANGE IN COURSE OF TREATMENT, OR ANY MEDICAL/SURGICAL INTERVENTION DUE TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21525792 ↗
• MalfunctionMay 20, 2022Break; Failure to Form Staple; Break; Failure to Form Staple

  AS REPORTED, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE ON (B)(6) 2022, THE BARD/DAVOL OPTIFIX AT WAS USED TO FIXATE A BARD MESH INTO THE SOFT TISSUE REGION IN THE STRAIGHT POSITION. AS REPORTED, THE FIRST FASTENER DID NOT FIXATE THE MESH AND THE SECOND FASTENER BROKE. AS REPORTED, THE PROUD/LOOSE FASTENERS WERE REMOVED FROM THE PATIENT BODY AND THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14462316 ↗
• MalfunctionApr 5, 2022Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING A PROCEDURE ON (B)(6) 2022, THE BARD/DAVOL OPTIFIX AT FIXATION DEVICE (DEVICE #1) MISFIRED SEVERAL TIMES AND FASTENERS WERE RELEASED SPORADICALLY. AS REPORTED, THE DEVICE WAS NOT USED AND A SECOND OPTIFIX AT (DEVICE #2) WAS OPENED, AND THE SAME ISSUE RECURRED. AS REPORTED, ALL FASTENERS WERE REMOVED FROM THE PATIENT'S BODY AND THERE WAS A PROCEDURAL DELAY IN COMPLETING THE CASE. THERE WAS NO REPORTED PATIENT INJURY. NOTE, THIS FILE REPRESENTS DEVICE #1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14015048 ↗
• MalfunctionApr 1, 2022Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING A PROCEDURE ON (B)(6) 2022, THE BARD/DAVOL OPTIFIX AT FIXATION DEVICE (DEVICE #1) MISFIRED SEVERAL TIMES AND FASTENERS WERE RELEASED SPORADICALLY. AS REPORTED, THE DEVICE WAS NOT USED AND A SECOND OPTIFIX AT (DEVICE #2) WAS OPENED, AND THE SAME ISSUE RECURRED. AS REPORTED, ALL FASTENERS WERE REMOVED FROM THE PATIENT'S BODY AND THERE WAS A PROCEDURAL DELAY IN COMPLETING THE CASE. THERE WAS NO REPORTED PATIENT INJURY. NOTE, THIS FILE REPRESENTS DEVICE #2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13977710 ↗
• MalfunctionOct 29, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED ON (B)(6) 2020, WHEN THE SURGEON OPENED THE PACKAGE OF AN OPTIFIX AT THERE WAS A "HAIR-LIKE" MATERIAL NOTED INSIDE THE STERILE PACKAGE WHICH LOOKED LIKE AN EYELASH PRIOR TO USE ON A PATIENT. THERE WAS NO REPORTED PATIENT INJURY BUT A SHORT DELAY OF FEW MINUTES WHILE RETRIEVING THE NEW DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10753926 ↗