BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUTPLUS DR EXT ASSY

    MDR report key: 2191271 · Received July 19, 2011

    Report

    Report Number
    1518293-2011-00125
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    October 7, 2010
    Report Date
    June 23, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) QUALITY ASSURANCE REVIEW OF COMPLAINT TRACKING SYSTEM FOR A SIMILAR ISSUE WITH A HUT SYSTEM FROM THIS HOSPITAL SHOWS THE ONLY UROLOGY TABLE SERVICE CALL TO THIS HOSPITAL IN (B)(6) 2010 WAS FOR A HUT SYSTEM SN (B)(4) FOR INTERMITTENT FLUORO (B)(4). THE FIELD SERVICE ENGINEER WAS DISPATCHED TO THE UNIT WHERE HE DETERMINED THE BIOMED HAD INCORRECTLY RESET GENERATOR DEFAULTS AFTER REPLACING A GENERATOR CONSOLE. UNIT PASSED CHECKOUT PROCEDURES AND WAS RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    A USER SUBMITTED MEDWATCH FORM WAS FOUND DURING A REVIEW PERFORMED ON (B)(6) 2011 OF THE MAUDE DATABASE. A SEARCH REVEALED THIS INCIDENT HAD NOT BEEN DOCUMENTED IN COVIDIEN'S COMPLAINT TRACKING SYSTEM. COVIDIEN WAS ABLE TO OBTAIN A COPY OF THE USER SUBMITTED 3500A. INFO ON FORM: DURING THE PROCEDURE (CYSTOSCOPY, RIGHT RETROGRADE, STENT INSERTION), THE RADIOGRAPHIC FUNCTION OF THE CYSTO TABLE STOPPED WORKING. RADIOLOGY WAS NOTIFIED BUT COULD NOT FIT THE PROBLEM. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? CYSTOSCOPY, RIGHT RETROGRADE, STENT INSERTION. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUTPLUS DR EXT ASSY UROLOGY SSYTEM KQS LIEBEL-FLARSHEIM CO. HUTPLUS DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR