BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPSY FORCEPS, 7 FR., SEMIFLEXIBLE

    MDR report key: 23852042 · Received December 19, 2025

    Report

    Report Number
    9610773-2025-08368
    Event Type
    Injury
    Date Received
    December 19, 2025
    Date of Event
    September 30, 2025
    Report Date
    February 25, 2026
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    NWW
    UDI-DI
    04042761006958
    PMA / PMN Number
    510(K) EXEMP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE APPROVED FINAL INVESTIGATION. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FIVE BIOPSY FORCEPS WERE DAMAGED ALL DUE TO THE FRACTURE OF THE FIXING PINS OF THE FORCEPS HEAD DURING AN UNSPECIFIED PROCEDURE. THE FIXING PIN OF THE FORCEPS HEAD FELL INTO THE PATIENT'S UTERINE CAVITY. THE FALLEN PART WAS RETRIEVED. THERE WERE NO REPORTS OF PATIENT HARM. THE REQUESTED ADDITIONAL INFORMATION FROM THE CUSTOMER IS CURRENTLY PENDING. THIS IS REPORT 4 OF 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2243380 BIOPSY FORCEPS, 7 FR., SEMIFLEXIBLE A4832 NWW OLYMPUS WINTER & IBE GMBH A4832 04042761006958

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention