BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE

    MDR report key: 372820 · Received January 19, 2002

    Report

    Report Number
    1527736-2002-00047
    Event Type
    Malfunction
    Date Received
    January 19, 2002
    Date of Event
    December 20, 2001
    Report Date
    December 20, 2001
    Manufacturer
    ETHICON ENDO-SURGERY - ALB
    Product Code
    LFL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REP. REPORTS THAT THE DEVICE WOULD NOT WORK OR WOULD WORK INTERMITTENTLY AT TIMES DURING A LAPAROSCOPIC DONOR NEPHRECTOMY. THE CUSTOMER TRIED TORQUING THE SHEARS, BUT THAT DID NOT WORK. THERE WERE NO PATIENT CONSEQUENCES, HOWEVER OPERATING ROOM TIME WAS EXTENDED BY 45 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE ULTRASONIC-SURGERY DEVICES - ENDOSC LFL ETHICON ENDO-SURGERY - ALB NA N4KR37

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other