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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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

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