BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPSY AND GRASPING FORCEPS, 5 FR.

    MDR report key: 21944959 · Received May 1, 2025

    Report

    Report Number
    9610617-2025-00749
    Event Type
    Malfunction
    Date Received
    May 1, 2025
    Report Date
    April 13, 2026
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    GCJ
    UDI-DI
    04048551094495
    PMA / PMN Number
    K934937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL BE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. 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

    PER INVESTIGATION BY THE MANUFACTURING SITE: A CONNECTING RIVET HAS COME LOOSE IN THE JOINT ON THE DISTAL SIDE. THIS IS DUE TO A MANUFACTURING DEFECT (INVESTIGATION CARRIED OUT BY THE SUPPLIER). THE WELD SEAM ON THE BACK PART WAS NOT DEEP ENOUGH. AN EMPLOYEE DID NOT DRILL THE HOLE DEEP ENOUGH. THE FOLLOWING INFORMATION CAN BE FOUND IN THE MANUFACTURER'S 8D REPORT (202452). "MAIN CAUSE / CAUSES: RIVET HAS COME LOOSE: WELD ON THE JAW PART NOT DEEP ENOUGH: COUNTERSINK ON THE JAW PART TOO SMALL. EMPLOYEE DID NOT COUNTERSINK CORRECTLY" THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SMALL PIN THAT HELPS THE GRASPER CLOSE ON ONE SIDE IS BROKEN. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619305 BIOPSY AND GRASPING FORCEPS, 5 FR. BIOPSY AND GRASPING FORCEPS, 5 FR. GCJ KARL STORZ SE & CO. KG 26159UHW YL01 04048551094495

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown