BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPSY FORCEPS, 3 FR., SEMIFLEXIBLE

    MDR report key: 19816187 · Received July 24, 2024

    Report

    Report Number
    9610773-2024-01791
    Event Type
    Malfunction
    Date Received
    July 24, 2024
    Date of Event
    July 4, 2024
    Report Date
    September 3, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    NWW
    PMA / PMN Number
    510KEXMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE LOT NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR INSPECTION, AND THE CUSTOMER'S REPORTABLE MALFUNCTION WAS NOT CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION AND THE INFORMATION PROVIDED, IT COULD NOT DETERMINE THE ROOT CAUSE, AND IT COULD NOT PRESUME THE CAUSE FROM THE OBTAINED INFORMATION. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE SCREW OF THE FLEXIBLE ENDOSCOPIC GRASPING FORCEPS FELL OFF. THE ISSUE OCCURRED DURING A THERAPEUTIC UTERINE CAVITY EXPLORATION PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350478 BIOPSY FORCEPS, 3 FR., SEMIFLEXIBLE FLEXIBLE ENDOSCOPIC GRASPING FORCEPS, REUSABLE NWW OLYMPUS WINTER & IBE GMBH A4820 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown