BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROBES, HL, RIWOLITH, 9FR

    MDR report key: 3959125 · Received May 20, 2014

    Report

    Report Number
    1418479-2014-00029
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 21, 2014
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    A FULL INVESTIGATION COULD NOT BE COMPLETED AS THE ACTUAL DEVICE WAS NOT RETURNED TO THE RICHARD WOLF FACILITY AS OF 05/20/2014. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. IE INTENDED USE, INDICATIONS AND FIELD OF USE, PREPARATION AND CAUTIONS. TRENDING SHOWED THERE HAS BEEN ONE SIMILAR INCIDENT IN THE LAST FOUR YEARS. (MDR1418479-2010-00020). RWMIC CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT WE RECEIVED THE DEVICE OR ADDITIONAL INFORMATION IS RECEIVED, WE WILL PROVIDE FDA WITH FOLLOW-UP INFORMATION.

    Description of Event or Problem · 1

    FACILITY NOTIFIED RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC) THAT DURING A LASER CYSTOLITHOLAPAXY PROCEDURE, THE DEVICE STOPPED FUNCTIONING. SURGEON SWITCHED TO ANOTHER SIMILAR DEVICE TO COMPLETE PROCEDURE. BEFORE PROCEDURE WAS COMPLETED SURGEON FOUND A METALLIC FOREIGN BODY IN THE BLADDER. FOREIGN BODY WAS RETRIEVED BY SURGEON. NO INJURY TO PT OR STAFF REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298989 PROBES, HL, RIWOLITH, 9FR PROBE DRF RICHARD WOLF MEDICAL INSTRUMENTS CORP 2135.0905 529131

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR