BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRASPING FORCEPS, 3 FR.

    MDR report key: 21289193 · Received January 31, 2025

    Report

    Report Number
    9610617-2025-00115
    Event Type
    Malfunction
    Date Received
    January 31, 2025
    Date of Event
    December 17, 2024
    Report Date
    March 6, 2025
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    OCZ
    UDI-DI
    04048551050545
    PMA / PMN Number
    K950434
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT EXPECTED TO BE RETURNED. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: AS THE DEVICE WAS NOT RETURNED TO KARL STORZ TUTTLTLINGEN A PHYSICAL EXAMINATION WAS NOT POSSIBLE. FURTHERMORE, NO LOT NUMBER WAS PROVIDED, THEREFORE A PRODUCT HISTORY REVIEW COULD NOT BE PERFORMED EITHER. THE LABELLING WAS FOUND TO CONTAIN ADEQUATE INSTRUCTIONS AND WARNINGS. ACCORDING TO THE CUSTOMER'S DESCRIPTION, A PART OF THE JAW OF ITEM 11274FE BROKE OFF IN THE BODY BUT COULD BE RECOVERED AFTERWARDS. A POSSIBLE CAUSE FOR THIS IS THAT IT WAS EITHER NOT USED FOR ITS INTENDED PURPOSE OR BROKE DUE TO MECHANICAL OVERLOAD. THE ITEM WAS NOT SENT TO KST FOR EXAMINATION, SO NO PRECISE STATEMENT IS POSSIBLE. THE AGE OF THE ITEM IS ALSO UNKNOWN, WHICH HAS A SIGNIFICANT IMPACT ON AN ARTICLE. IF NEW OR ADDITIONAL RELEVANT INFORMATION WILL BE RECEIVED, WE WILL REOPEN THE INVESTIGATION ACCORDINGLY. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PROBLEM THE JAWS OF THE GRASPER BROKE OFF INSIDE THE PATIENT. THE BROKEN FOREIGN BODY WAS REMOVED WITH ANOTHER GRASPER AND ALL PIECES WERE CONFIRMED REMOVED FROM THE PATIENT. STAFF ALSO REPORTED THAT THE GRASPER OFTEN DOES NOT OPEN WHEN TRIGGERED BY THE PROCEDURALS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2231279 GRASPING FORCEPS, 3 FR. GRASPING FORCEPS, 3 FR. OCZ KARL STORZ SE & CO. KG 11274FE 04048551050545

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown