BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KARL STORZ

    MDR report key: 3447095 · Received September 30, 2013

    Report

    Report Number
    9610617-2013-00036
    Event Type
    Injury
    Date Received
    September 30, 2013
    Report Date
    September 27, 2013
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    HIN
    PMA / PMN Number
    K061541
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    NO KS PRODUCT WAS RETURNED BECAUSE THE HOSPITAL DETERMINED THAT IT WAS A MALFUNCTION OF THE COVIDIEN FORCE TRIAD ESU WHICH CAUSED EXCESSIVE ENERGY WHEN INSTRUMENTS WERE ACTIVATED RESULTING IN THE PERFORATION. THE UNIT WAS SENT TO COVIDIEN IN (B)(4) 2013 FOR SERVICE FOR BAD BIPOLAR OUTPUT. COVIDIEN COULD NOT CONFIRM THAT ISSUE AND PERFORMED CALIBRATION AND PREVENTATIVE MAINTENANCE AND RETURNED UNIT TO THE HOSP; NO REPAIRS WERE DONE. AFTER THE PERFORATION OCCURRED, UNIT WAS SENT BACK AGAIN FOR EVAL. COVIDIEN EVAL REPORT PROVIDED TO THE HOSPITAL ((B)(4) 2013): HOSPITAL'S STATED REASON FOR RETURN: WHILE DOING A BIPOLAR RESECTION OF THE PROSTRATE, THE UNIT WAS NOT WORKING PROPERLY. AT LOW WATTAGE, THERE WAS NO POWER AND WHEN THEY PUT HIGHER WATTAGE IT WAS TOO STRONG AND THE ENERGY PERFORATED THE BLADDER. COVIDIEN EVAL AND REPAIR TEXT: RECEIVED UNIT WITH NO ECODE AND SW 3.5. LAST CALIBRATION PERFORMED (B)(4) 2013. DURING INSPECTION WE FOUND A NON-FUNCTIONAL MECHANISM IN THE LIGASURE 2 PORT. REALIGNMENT OF THE MECHANISM FIXED. CANNOT READ ANY DEVIATION OF THE DIRECT RF ENERGY EVEN THE LEAKAGE CURRENT FROM 6 PORTS. ALL PERFORMANCE AND VERIFICATION DONE AS RECOMMENDED BY MFG. NEW SOFTWARE INSTALLED (3.6) COMPLETE INSPECTION DONE. ESU PASSED PVT.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492751 KARL STORZ BIPOLAR ELECTRODE HIN KARL STORZ GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1