BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROBES, EHL, RIWOLTH, 9FR

    MDR report key: 4842092 · Received June 9, 2015

    Report

    Report Number
    1418479-2015-00016
    Event Type
    Malfunction
    Date Received
    June 9, 2015
    Date of Event
    May 11, 2015
    Report Date
    May 27, 2015
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Product Code
    FFK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A FULL INVESTIGATION WAS COMPLETED AS THE ACTUAL DEVICE WAS RETURNED TO THE RWMIC FACILITY ON 05/29/2015. INVESTIGATION REVEALED END OF DEVICE WAS FLARED OUT MOST LIKELY DUE TO DEVICE BEING ACTIVATED WHILE OUT OF LIQUID. INSERTION OF DEVICE INTO PATIENT AND MOVEMENT WITHIN PATIENT CAUSED DEVICE TO THEN BREAK. DEVICE HAD NO MISSING BLUE PLASTIC. MFR DATE: 08/2014. (B)(6). 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 (MDR#: 1418479-2015-00029). RWMIC CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT WE RECEIVE THE DEVICE OR ADDITIONAL INFO IS RECEIVED, WE WILL PROVIDE FDA WITH F/U INFO.

    Description of Event or Problem · 1

    FACILITY NOTIFIED RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC) THAT DURING A PROCEDURE TO REMOVE BLADDER STONES, INSTRUMENT BROKE INTO PIECES. SURGEON WAS ABLE TO RETRIEVE FOREIGN OBJECTS AND THEN SWITCHED TO ANOTHER SIMILAR DEVICE TO COMPLETE PROCEDURE. DELAY IN PROCEDURE TO REMOVE FOREIGN OBJECTS BUT NO INJURY TO PATIENT OR STAFF REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371010 PROBES, EHL, RIWOLTH, 9FR PROBE FFK RICHARD WOLF MEDICAL INSTRUMENTS CORP. 2135.0905 51001692

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR