DISPOSABLE GRASPING FORCEPS FG-402QRecalls & reported problems
Olympus Medical Systems Corp. · DISPOSABLE GRASPING FORCEPS · Class 2
All models of DISPOSABLE GRASPING FORCEPS (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170143182), received between Dec 10, 2021 and Dec 10, 2021 — classified as 1 injury.
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.
Most reported problems
Device problems
- Break1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 10, 2021Break; Break
THE CUSTOMER REPORTS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A SINGLE USE, FOUR-WIRE STONE-EXTRACTION BASKET (FG-402Q) DEVICE TO ATTEMPT EXTRACTION OF A BILIARY STONE. WHEN THE PHYSICIAN ATTEMPTED TO PULL IT OUT, THE BASKET WAS STUCK INSIDE THE BILIARY DUCT. THE HANDLE FINALLY BROKE SO THE STONE COULD NOT BE EXTRACTED. DUE TO THE BASKET BEING STUCK INSIDE THE PATIENT, SURGICAL INTERVENTION WAS REQUIRED TO EXTRACT BOTH THE STONE AND BASKET. NO EQUIPMENT WAS REPLACED. THE PLANNED PROCEDURE WAS NOT COMPLETED. NO ADDITIONAL CONSEQUENCES TO THE PATIENT HAVE BEEN REPORTED AS A RESULT OF THIS OCCURRENCE. THE BASKET DEVICE WAS DISCARDED BY THE CUSTOMER AND WILL NOT BE RETURNED TO OLYMPUS FOR EVALUATION. THE SCOPE USED IN THE PROCEDURE DID NOT MALFUNCTION IN ANY WAY.
Patient problems: Foreign Body In Patient
MAUDE report 12981070 ↗
Other Endoscopic grasping/cutting instrument, non-powered devices
- diagnostic FTRD Set 13Ovesco Endoscopy AG · Endoscopic Grasping/Cutting Instrument, Non-Powered13 reports
- Single Use Retrieval Basket V FG-V422PROlympus Medical Systems Corp. · Endoscopic grasping/cutting instrument, non-powered1 death11 reports
- Single Use Retrieval Basket V FG-V432POlympus Medical Systems Corp. · Endoscopic grasping/cutting instrument, non-powered11 reports
- n.a. 27072AKarl Storz GmbH & Co. KG · Endoscopic grasping/cutting instrument, non-powered9 reports
- n.a. 27074BKarl Storz GmbH & Co. KG · Endoscopic grasping/cutting instrument, non-powered9 reports
- Raptor 00711177US Endoscopy · Endoscopic grasping/cutting instrument, non-powered8 reports
- n.a. 27071TJKarl Storz GmbH & Co. KG · Endoscopic grasping/cutting instrument, non-powered6 reports
- Raptor 00711178US Endoscopy · Endoscopic grasping/cutting instrument, non-powered5 reports
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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