Skip to content

USA Elite E8213Recalls & reported problems

Gyrus ACMI, LLC · USA Elite System Rigid Optical Cup Tearing Biopsy Forceps · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821925001237), received between Mar 15, 2023 and Mar 15, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical 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

Device problems

  • Mechanical Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionMar 15, 2023Mechanical Problem; Mechanical Problem

    CUSTOMER REPORTED THE" GRASPER IS NOT WORKING, HANDLE IS NOT WORKING". THE REPORTED ISSUE FOUND DURING AN UNKNOWN EVENT. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16543982 ↗

Other FORCEPS, GENERAL & PLASTIC SURGERY devices

All FORCEPS, GENERAL & PLASTIC SURGERY devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.