BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 8296547 · Received February 1, 2019

    Report

    Report Number
    8296547
    Event Type
    Malfunction
    Date Received
    February 1, 2019
    Date of Event
    January 9, 2019
    Report Date
    January 22, 2019
    Manufacturer
    OLYMPUS WINTER IBE GMBH
    Product Code
    NLW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHILE THE DOCTOR WAS USING THE BUTTON TURP LOOP, THE LOOP BROKE WHILE CAUTERIZING THE PROSTATE. THE ENDS OF THE LOOP CURLED UP. ENTIRE LOOP IS STILL THERE, JUST CURLED UP AT THE ENDS. NEW LOOP OBTAINED AND THE PROCEDURE CONTINUED WITH NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90696 OLYMPUS ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL NLW OLYMPUS WINTER IBE GMBH WA22607D 806847

    Patients

    Seq Age Sex Outcome Treatment
    1 24090 DA