DISPOSABLE GRASPING FORCEPS(PARALLEL BASKET TYPE,3Fr.) FG-51DRecalls & reported problems
Olympus Medical Systems Corp. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04953170060564), received between May 5, 2022 and Oct 16, 2024 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent4
- Mechanical Problem2
- Deformation Due to Compressive Stress1
- Material Split, Cut or Torn1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 16, 2024Unintended Movement; Unintended Movement
IT WAS REPORTED THE DISPOSABLE GRASPING FORCEPS IMPACTED A STONE WHEN ATTEMPTING TO GRASP AND EXTRACT IT. THE ISSUE OCCURRED DURING A PERCUTANEOUS CHOLANGIOSCOPY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20462736 ↗MalfunctionSep 12, 2022Material Twisted/Bent; Material Twisted/Bent
THE CUSTOMER REPORTED THAT, DURING PREPARATION FOR AN UNSPECIFIED PROCEDURE, THE BASKET OF THE SUBJECT DEVICE DID NOT CLOSE WHEN TESTED. THREE ADDITIONAL DEVICES WERE TESTED WITH THE SAME RESULT. THE PROCEDURE WAS COMPLETED USING THE FIFTH DEVICE THAT WAS OPENED. THERE WAS NO EFFECT ON THE PATIENT DUE TO THE EVENT. THIS REPORT IS FOR THE SECOND DEVICE. THE FIRST DEVICE IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). THE THIRD DEVICE IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). THE FOURTH DEVICE IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15407866 ↗MalfunctionSep 12, 2022Material Twisted/Bent; Material Twisted/Bent
THE CUSTOMER REPORTED THAT, DURING PREPARATION FOR AN UNSPECIFIED PROCEDURE, THE BASKET OF THE SUBJECT DEVICE DID NOT CLOSE WHEN TESTED. THREE ADDITIONAL DEVICES WERE TESTED WITH THE SAME RESULT. THE PROCEDURE WAS COMPLETED USING THE FIFTH DEVICE THAT WAS OPENED. THERE WAS NO EFFECT ON THE PATIENT DUE TO THE EVENT. THIS REPORT IS FOR THE THIRD DEVICE. THE FIRST DEVICE IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). THE SECOND DEVICE IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). THE FOURTH DEVICE IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15407861 ↗MalfunctionSep 12, 2022Material Twisted/Bent; Material Twisted/Bent
THE CUSTOMER REPORTED THAT, DURING PREPARATION FOR AN UNSPECIFIED PROCEDURE, THE BASKET OF THE SUBJECT DEVICE DID NOT CLOSE WHEN TESTED. THREE ADDITIONAL DEVICES WERE TESTED WITH THE SAME RESULT. THE PROCEDURE WAS COMPLETED USING THE FIFTH DEVICE THAT WAS OPENED. THERE WAS NO EFFECT ON THE PATIENT DUE TO THE EVENT. THIS REPORT IS FOR THE FIRST DEVICE. THE SECOND DEVICE IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). THE THIRD DEVICE IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). THE FOURTH DEVICE IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15407860 ↗MalfunctionSep 12, 2022Material Twisted/Bent; Material Twisted/Bent
THE CUSTOMER REPORTED THAT, DURING PREPARATION FOR AN UNSPECIFIED PROCEDURE, THE BASKET OF THE SUBJECT DEVICE DID NOT CLOSE WHEN TESTED. THREE ADDITIONAL DEVICES WERE TESTED WITH THE SAME RESULT. THE PROCEDURE WAS COMPLETED USING THE FIFTH DEVICE THAT WAS OPENED. THERE WAS NO EFFECT ON THE PATIENT DUE TO THE EVENT. THIS REPORT IS FOR THE FOURTH DEVICE. THE FIRST DEVICE IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). THE SECOND DEVICE IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). THE THIRD DEVICE IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15407857 ↗MalfunctionSep 9, 2022Deformation Due to Compressive Stress; Material Split, Cut or Torn; Deformation Due to Compressive Stress; Material Split, Cut or Torn
THE CUSTOMER REPORTED THAT, AFTER UNFOLDING THE BASKET WIRE OF THE SUBJECT DEVICE DURING A PERCUTANEOUS COMMON BILE DUCT STONE REMOVAL PROCEDURE, IT COULD NOT BE STORED IN THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER SIMILAR DEVICE. DURING PRE-USE INSPECTION OF THE DEVICE, THE USER NOTICED THE DEVICE WAS STUCK AND DID NOT MOVE SMOOTHLY BUT THE BASKET WAS ABLE TO BE STORED AND IT WAS USED IN THE CASE. THERE WAS NO EFFECT ON THE PATIENT DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15392733 ↗MalfunctionMay 5, 2022Mechanical Problem; Mechanical Problem
A USER FACILITY REPORTED TO OLYMPUS, THE DISPOSABLE GRASPING FORCEPS (PARALLEL BASKET TYPE,3FR.) WAS OPENING BUT DID NOT CLOSE. THE EVENT OCCURRED DURING AN UNKNOWN THERAPEUTIC PROCEDURE. IT WAS REPORTED THE ISSUE OCCURRED TWICE, AND THE SUSPECTED DEVICE WAS REPLACED. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIER (B)(6) (FIRST EVENT).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14286819 ↗MalfunctionMay 5, 2022Mechanical Problem; Mechanical Problem
A USER FACILITY REPORTED TO OLYMPUS, THE DISPOSABLE GRASPING FORCEPS (PARALLEL BASKET TYPE,3FR.) WAS OPENING BUT DID NOT CLOSE. THE EVENT OCCURRED DURING AN UNKNOWN THERAPEUTIC PROCEDURE. IT WAS REPORTED THE ISSUE OCCURRED TWICE, AND THE SUSPECTED DEVICE WAS REPLACED. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIER (B)(6) (SECOND EVENT).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14286689 ↗
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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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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