BEUDAMED
    FDA Adverse Event Other Summary report: N

    WOF RESECTOSCOPE SHEATH SIZE 24

    MDR report key: 3851396 · Received May 30, 2014

    Report

    Report Number
    MW5036456
    Event Type
    Other
    Date Received
    May 30, 2014
    Date of Event
    May 10, 2014
    Report Date
    May 29, 2014
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP
    Product Code
    FDC
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT A GREENLIGHT LASER XPS, ABLATION OF PROSTATE (MANUFACTURER AMS) IN CONJUNCTION WITH USING A RESECTOSCOPE SHEATH MANUFACTURED BY WOLF. TOWARDS THE END OF PROCEDURE THE TIP OF THE SHEATH SHATTERED OFF INTO THE PT. THE TIP OF THE SHEATH IS MADE OF CERAMIC. ALL PARTICLES WERE RETRIEVED FROM PT. NO INJURY TO PT. MANUFACTURE NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319889 WOF RESECTOSCOPE SHEATH SIZE 24 RESECTOSCOPE FDC RICHARD WOLF MEDICAL INSTRUMENTS CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR