USA Elite E8215Recalls & reported problems
Gyrus ACMI, LLC · USA Elite System Rigid Optical Grasping Forceps · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821925001244), received between Mar 15, 2023 and Apr 24, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem2
- Break1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THE ELITE RIGID OPTICAL GRASPING FORCEPS EXPERIENCED OPTICAL TEETH ARE NOT LINING UP ISSUE DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21902037 ↗InjuryOct 2, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
NO ERROR MESSAGES THAT MAY HAVE BEEN OBSERVED AS A RESULT OF THE FAILURE. THE PROCEDURE WAS NOT PROLONGED. THE PROCEDURE DID NOT NEED TO BE CANCELLED OR POSTPONED. THE PROCEDURE WAS COMPLETED WITH MULTIPLE FOGARTYS. THE REPORTED PROBLEM DID NOT AFFECT THE DIAGNOSTIC OR THERAPEUTIC OUTCOME OF THE PROCEDURE. NO OTHER DEVICES CONNECTED TO THE SUBJECT DEVICE WHEN THE FAILURE OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17855668 ↗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 16543919 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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