NA 9626-02-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295243281), received between Mar 16, 2020 and Jun 23, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2021Break; Material Twisted/Bent; Naturally Worn; Break; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT THERE WERE BROKEN AND WORN ITEMS PICKED UP BY THE STERILIZATION DEPARTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12053865 ↗
• MalfunctionMar 16, 2020Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  THESE INSTRUMENT TRIALS HAVE BEEN MELTED IN THE WASHER AT THE ACCOUNT AND ARE NOT FIT FOR PURPOSE NOW.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9837506 ↗