BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE

    MDR report key: 304435 · Received November 13, 2000

    Report

    Report Number
    1527736-2000-05681
    Event Type
    Injury
    Date Received
    November 13, 2000
    Date of Event
    January 27, 2000
    Report Date
    October 27, 2000
    Manufacturer
    ETHICON ENDO-SURGERY - ALB
    Product Code
    LFL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (2) DEVICES WERE USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED BY THE REP THAT BOTH OF THE LCSC5 SHEARS, WOULD WORK EFFECTIVELY FOR A FEW MINUTES AND THEN STOPPED WORKING (LOCKEDOUT). THE PT WAS THEN CONVERTED TO AN OPEN PROCEDURE. THE OR CASE WAS EXTENDED AND THE PATIENT HOSPITAL STAY WAS EXTENDED. 11/01/2000 MESSAGE FROM REP. THE HP052 WAS USED. THE HOSPITAL STAY WAS 2 DAYS AND THE CONVERT TO OPEN EXTENDED THE CASE 90 MINUTES. THE PT IS CURRENTLY DISCHARGED.

    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 N4JF1X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention