OPTIFIX 0113320Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741128950), received between Jul 17, 2019 and Jul 17, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED BY THE BD SALES REP. THAT DURING AN OPEN UMBILICAL HERNIA REPAIR, THE SURGEON WAS USING THE OPTIFIX OPEN FIXATION DEVICE FOR THE FIRST TIME. THE SALES REP. ADVISED THE SURGEON TO USE ADEQUATE COUNTER PRESSURE. THE SURGEON'S PHYSICIAN'S ASSISTANT APPLIED COUNTER PRESSURE ON TOP ON THE FASCIA AND UNDER THE SKIN AND SUBQ FAT. AT THE FIRST FIRE, THE PHYSICIAN'S ASSISTANT WAS HIT IN THE FINGER AND THROUGH HER GLOVE WITH THE GUIDE WIRE. THE CASE WAS FINISHED AND THE PHYSICIAN'S ASSISTANT HAD HER BLOOD DRAWN.

  Patient problems: Needle Stick/Puncture

  MAUDE report 8798237 ↗