BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRASPING FORCEPS, SHARK TEETH, 5 FR., SEMIFLEXIBLE

    MDR report key: 23237655 · Received October 7, 2025

    Report

    Report Number
    9610773-2025-06228
    Event Type
    Malfunction
    Date Received
    October 7, 2025
    Date of Event
    September 8, 2025
    Report Date
    October 7, 2025
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    NWW
    PMA / PMN Number
    N/A
    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: WIRE (SHAFT) THAT PUSHES AND PULLS THE FORCEPS PORT (JAWS) WAS FRACTURED AT THE CONNECTING SECTION TO THE HANDLE. 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 WIRE (SHAFT) THAT PUSHES AND PULLS THE FORCEPS PORT (JAWS) WAS FRACTURED AT THE CONNECTING SECTION TO THE HANDLE. THE SPRING INSIDE THE HANDLE IS DEFORMED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2746934 GRASPING FORCEPS, SHARK TEETH, 5 FR., SEMIFLEXIBLE FLEXIBLE ENDOSCOPIC GRASPING FORCEPS, REUSABLE NWW OLYMPUS WINTER & IBE GMBH A4825

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown