BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPSY FORCEPS, 7 FR., SEMIFLEXIBLE

    MDR report key: 23524489 · Received November 11, 2025

    Report

    Report Number
    9610773-2025-06966
    Event Type
    Malfunction
    Date Received
    November 11, 2025
    Date of Event
    October 16, 2025
    Report Date
    November 11, 2025
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    NWW
    UDI-DI
    04042761006958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: CAUSE TRACED TO COMPONENT FAILURE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED THE HANDLE THAT COULD NOT CONTROL THE OPENING AND CLOSING OF THE FORCEPS, DEFORMED JOINT AT THE CONNECTION POINT OF FORCEPS PORT (JAWS), THE PIN IS MISSING AND COMPONENT FAILURE OF THE FORCEPS PORT (JAWS). THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1934605 BIOPSY FORCEPS, 7 FR., SEMIFLEXIBLE A4832 NWW OLYMPUS WINTER & IBE GMBH A4832 04042761006958

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown