BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE

    MDR report key: 369859 · Received January 2, 2002

    Report

    Report Number
    1527736-2001-06366
    Event Type
    Malfunction
    Date Received
    January 2, 2002
    Date of Event
    November 12, 2001
    Report Date
    December 11, 2001
    Manufacturer
    ETHICON ENDO-SURGERY - ALB
    Product Code
    LFL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LAPAROSONIC COAGULATION SHEAR CURVE WAS USED DURING A LAPAROSCOPIC NEPHRECTOMY. IT WAS REPORTED THAT THE DEVICE WORKED INITIALLY, BUT ABOUT HALFWAY INTO THE CASE, IT BEGAN TO LOCKOUT CONTINUOUSLY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PATIENT.

    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 P4NE7F

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other GENERATOR, FOOTSWITCH AND HANDPIECE.