BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS PLASMALOOP 12-30 DEGREE

    MDR report key: 22359973 · Received June 30, 2025

    Report

    Report Number
    MW5172096
    Event Type
    Malfunction
    Date Received
    June 30, 2025
    Date of Event
    June 4, 2025
    Report Date
    June 25, 2025
    Manufacturer
    UNK
    Product Code
    NLW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT HAS HISTORY OF UROLIFT IMPLANT WHICH CAUSED THE OLYMPUS PLASMALOOP TO BREAK GETTING CAUGHT ON IMPLANT DURING RESECTION. OLYMPUS WINTER & IBE GMBH, HAMBURG, 22045 DE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1419184 OLYMPUS PLASMALOOP 12-30 DEGREE ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL, REPROCESSED NLW UNK WA22706S 1000167816

    Patients

    Seq Age Sex Outcome Treatment
    1 Male