BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORCEPS

    MDR report key: 23854601 · Received December 19, 2025

    Report

    Report Number
    9610617-2025-02345
    Event Type
    Injury
    Date Received
    December 19, 2025
    Date of Event
    November 28, 2025
    Report Date
    December 19, 2025
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    FGA
    UDI-DI
    04048551082485
    PMA / PMN Number
    K232370
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS NOT RETURNED AT THE TIME OF MDR SUBMISSION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE TIP OF THE FORCEPS BROKE OFF. THE BROKEN PART INCLUDED WITH THE FORCEPS WAS RETRIEVED AFTER THE PROCEDURE. WE REQUEST CONFIRMATION THAT NO OTHER BROKEN PARTS (FRAGMENTS) ARE PRESENT. THEY WERE NOT VISIBLE ON X-RAY OR CT IMAGES. SINCE IT WAS INDICATED THAT MEDICAL/ SURGICAL/ DIAGNOSTICAL INTERVENTION WAS REQUIRED AND IT COULD NOT YET BE CONFIRMED IF OTHER FRAGMENTS ARE PRESENT, THIS CASE IS DEEMED REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2627534 FORCEPS FORCEPS FGA KARL STORZ SE & CO. KG 27290K UN03 04048551082485

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O