OPTIFIXRecalls & reported problems across all models

We found 5 models of OPTIFIX by Davol Inc. in the FDA's device registry (GUDID). Together they are named in 367 adverse event reports in the FDA's MAUDE database, received between Mar 22, 2017 and Sep 23, 2026 — classified as 11 injuries, 356 malfunctions.

The most frequently reported specific device problem is “Break” (175 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported OPTIFIX problems

OPTIFIX models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• OPTIFIX 0113126

  STAPLE, IMPLANTABLE
  176 reports
• OPTIFIX 0113127

  STAPLE, IMPLANTABLE
  118 reports
• OPTIFIX 0113330

  Staple, implantable
  67 reports
• OPTIFIX 0113315

  Staple, implantable
  5 reports
• OPTIFIX 0113320

  STAPLE, IMPLANTABLE
  1 report

Recent OPTIFIX adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873032 ↗
• MalfunctionSep 4, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50615626 ↗
• MalfunctionAug 20, 2026Failure to Form Staple

  As reported on 28-Jul-2026, during a laparoscopic left inguinal hernia repair halfway through the use of the OptiFix fixation device, it did not "fully tack the mesh down, when the resident was attempting to use it." "The surgeon took over and after a few more failed attempts, when pulling the trigger, there was a jam and it did not release anything." The procedure was completed with another device. There was no patient harm or injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50346384 ↗
• MalfunctionAug 14, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50258084 ↗
• MalfunctionAug 13, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50237927 ↗
• MalfunctionJun 29, 2026Failure to Form Staple

  AS REPORTED, DURING A TAPP PROCEDURE, THE HEALTH PROFESSIONAL ATTEMPTED TO SECURE THE MESH USING OPTIFIX STRAIGHT FIXATION DEVICE; HOWEVER, THREE (3) CONSECUTIVE FASTENERS FAILED TO PENETRATE THE TISSUE AND FELL OUT. REPORTEDLY, THE FASTENERS WERE DEPLOYED INTO THE LIGAMENT AREA, AND THE LOOSE FASTENERS WERE SUBSEQUENTLY REMOVED FROM THE PATIENT'S BODY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25653272 ↗
• MalfunctionJun 11, 2026Failure to Form Staple; Material Twisted/Bent

  AS REPORTED, DURING THE PROCEDURE WHILE STAPLING IN THE COOPER'S LIGAMENT USING OPTIFIX STRAIGHT FIXATION DEVICE, THE STAPLER APPARENTLY SLIPPED, CAUSING THE PILOT TIP (GUIDEWIRE) TO BEND, WHICH PREVENTED SUBSEQUENT STAPLES FROM BEING EJECTED. REPORTEDLY, TWO STAPLES COULD BE PLACED ON EITHER SIDE OF THE INFERIOR ABDOMINAL WALL ARTERIES AND VEINS, AND ONE ON THE INNER SIDE. THE LOOSE AND BROKEN FASTENERS WERE REMOVED FROM PATIENT'S BODY. THE SURGEON WAS THE FIRST-TIME USER OF THE DEVICE AND DRY FRIED THE DEVICE TO CHECK THE PROBLEM RE-OCCURRENCE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25472374 ↗
• MalfunctionMay 27, 2026Break

  AS REPORTED, DURING THE PROCEDURE USING THE OPTIFIX ABSORBABLE FIXATION DEVICE, IT WAS OBSERVED THAT THE FASTENERS FAILED TO FIXATE AND BROKE ON THE FIRST FIRE. REPORTEDLY, THE FIRST FIXATION DEVICE IS DAMAGED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25304390 ↗
• MalfunctionMay 13, 2026Failure to Form Staple

  AS REPORTED, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2026, THE SURGEON ATTEMPTED TO FIXATE THE MESH USING AN OPTIFIX AT FIXATION DEVICE; HOWEVER, DESPITE SEVERAL ATTEMPTS, THE FASTENERS FAILED TO PROPERLY SECURE THE MESH. THE LOOSE FASTENERS WERE REMOVED FROM THE PATIENT AND ANOTHER FIXATION DEVICE TO COMPLETED THE PROCEDURE. THE SURGEON APPLIED COUNTER PRESSURE BUT WAS UNSUCCESSFUL IN FIXATING THE MESH. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25162140 ↗
• MalfunctionMay 13, 2026Failure to Form Staple

  AS REPORTED, DURING A HERNIA REPAIR PROCEDURE, THE OPTIFIX AT FASTENERS FAILED TO FIXATE THE MESH. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25162137 ↗
• MalfunctionApr 16, 2026Failure to Form Staple

  AS REPORTED, DURING A LAPAROSCOPIC INCISIONAL HERNIA REPAIR THE OPTIFIX FIXATION DEVICE FAILED TO SECURE THE MESH AND THE FASTENERS WERE OBSERVED TO FALL OUT. THE SURGEON ATTEMPTED SEVERAL TIMES BUT FAILED TO FIXATE SUCCESSFULLY. ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24896734 ↗
• MalfunctionApr 13, 2026Failure to Form Staple

  AS REPORTED, DURING LAPAROSCOPIC VENTRAL HERNIA REPAIR USING OPTIFIX AT FASTENERS DIDN'T PENETRATE THE TISSUE AND FAILED TO FIXATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24857754 ↗
• MalfunctionApr 9, 2026Failure to Form Staple

  AS REPORTED, DURING REPAIR OF AN ABDOMINAL WALL INCISIONAL HERNIA PROCEDURE, THE OPTIFIX FASTENERS FAILED TO FIXATE THE MESH, AND SLIPPED INTO THE ABDOMINAL CAVITY. THE LOOSE FASTENERS WERE RETRIEVED FROM THE PATIENT'S BODY. REPORTEDLY, FIVE TO SIX ATTEMPTS WERE MADE BUT NONE GOT FIXATED. IT WAS ALSO REPORTED THAT INITIALLY ANOTHER PRODUCT WAS USED FOR FIXATION AND FOR ADDITIONAL FIXATION THE ALLEGED DEVICE WAS USED. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24830210 ↗
• MalfunctionApr 2, 2026Failure to Form Staple

  AS REPORTED, DURING THE BILATERAL LAPAROSCOPIC INGUINAL PLASTY PROCEDURE, THE OPTIFIX FASTENERS CAME OUT SIDEWAYS (CROOKED). THE ISSUE OCCURRED FROM THE FIRST FIRING AND NONE OF THE FASTENERS GOT FIXATED. REPORTEDLY, THERE WERE NO PROTRUDING OR LOOSE FASTENERS PRESENT AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24767366 ↗
• MalfunctionMar 30, 2026Failure to Form Staple

  AS REPORTED, DURING A LAPAROSCOPIC ABDOMINAL WALL SCAR HERNIA REPAIR PROCEDURE, WHILE FIXATING THE VENTRALIGHT ST WITH ECHO 2 MESH, THE OPTIFIX FASTENER FAILED TO COME OUT FROM THE MIDDLE OF THE DEVICE AND THE TIP OF THE DEVICE WAS FOUND TO BE BROKEN. THE SURGEON APPLIED ADEQUATE COUNTER PRESSURE WHILE SECURING THE FASTENERS. IT WAS REPORTED THAT THE FASTENER WAS RETRIEVED FROM THE PATIENT'S BODY, WHICH COULD NOT BE FIXATED. ANOTHER FIXATION DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716132 ↗

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