BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 9792864 · Received March 4, 2020

    Report

    Report Number
    MW5093517
    Event Type
    Malfunction
    Date Received
    March 4, 2020
    Date of Event
    December 17, 2019
    Report Date
    March 2, 2020
    Manufacturer
    OLYMPUS SURGICAL TECHNOLOGIES AMERICA
    Product Code
    FJL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE TIP OF THE RESECTOSCOPE BROKE DURING A TRANSURETHRAL RESECTION OF A PROSTATE. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PIECE OF THE SCOPE WITH A GRASPER. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253493 OLYMPUS RESECTOSCOPE FJL OLYMPUS SURGICAL TECHNOLOGIES AMERICA A22040A 182W-0250

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR