NA 03.010.088Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982067586), received between Aug 3, 2021 and Aug 3, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionAug 3, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INSPECTION OF THE INSTRUMENTS AFTER GOING TO DECONTAMINATION PROCESS, IT WAS NOTICED THAT A TROCAR WAS BENT AND WAS INADVERTENTLY PLACED IN THE SHARP¿S CONTAINER, A REAMING ROD PUSH ROD WITH BALL HANDLE WAS ALSO FOUND BENT AND HAS SCUFF MARKINGS ON IT WHERE IT LOOKS LIKE IT IS GETTING JAMMED UP IN THE DRILLS BECAUSE IT IS BENT, AND THE WHOLE TIP OF A DEPTH GAUGE BROKE OFF COMPLETELY. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES (3) DEVICES. THIS REPORT IS FOR (1) 2.0MM TROCAR 150MM. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12268621 ↗