Gyrus ACMI RWG-337RRecalls & reported problems
Gyrus ACMI, LLC · Rigid Windowed (Fenestrated) Rotating Grasping Forceps, 3 MM, 37 CM · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821925008342), received between Jun 2, 2023 and Nov 25, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
- Material Separation1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 25, 2025Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23644236 ↗InjuryJun 2, 2023Break; Break
THE CUSTOMER REPORTED TO OLYMPUS THAT DURING PERCUTANEOUS NEPHROLITHOTOMY, THIS GRASPING FORCEPS BROKE. THE PIN THAT HOLDS THE JAWS IN PLACE WAS MISSING AND PRESUMED THAT IT IS INSIDE THE PATIENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WAS MADE, HOWEVER, UNSUCCESSFUL. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.
Patient problems: Foreign Body In Patient
MAUDE report 17051299 ↗
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- NA M0061802010Boston Scientific Corporation · SURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES)1 report
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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