BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPSY FORCEPS, 5 FR., SEMIFLEXIBLE

    MDR report key: 19872631 · Received July 31, 2024

    Report

    Report Number
    9610773-2024-01847
    Event Type
    Malfunction
    Date Received
    July 31, 2024
    Date of Event
    July 17, 2024
    Report Date
    September 22, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    NWW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE G3 OF THE INITIAL MEDWATCH. THE AWARE DATE SHOULD BE 07-26-2024.

    Additional Manufacturer Narrative · 0

    E1: (B)(6) HOSPITAL. THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNKNOWN DIAGNOSTIC SURGERY, A SCREW FELL OFF THE BIOPSY FORCEPS AND INTO THE PATIENT'S BODY. THE SCREW WAS RETRIEVED, AND THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885092 BIOPSY FORCEPS, 5 FR., SEMIFLEXIBLE FORCEPS, BIOPSY NWW OLYMPUS WINTER & IBE GMBH A4824 23ZW

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CV-190