BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE

    MDR report key: 296224 · Received September 13, 2000

    Report

    Report Number
    1527736-2000-04311
    Event Type
    Injury
    Date Received
    September 13, 2000
    Date of Event
    August 16, 2000
    Report Date
    August 16, 2000
    Manufacturer
    ETHICON ENDO-SURGERY - ALB
    Product Code
    LFL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE LCSC5 WAS USED DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY. IT WAS REPORTED BY THE REP THAT THE INSTRUMENT LOCKED OUT CONTINUOUSLY THROUGHOUT THE CASE. THE REP ADVISED THEM TO REGRASP THE TISSUE, RE-TORQUE THE INSTRUMENT, CLEAN OFF THE BLADE, AND NOT TRY TO TRANSECT PREVIOUSLY DESSICATED TISSUE. ALL CONNECTIONS, INCLUDING THE FOOTPAD, WERE CHECKED WITHOUT PERMANENT RESOLUTION TO THE LOCKOUT PERFORMANCE. A NEW INSTRUMENT WAS OPENED WITH THE SAME PROBLEM. THE CASE WAS CONVERTED TO OPEN HYSTERECTOMY BECAUSE BLEEDING WAS NOT CONTROLLED WITH HARMONIC SCALPEL OR TRI-POLAR.

    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 N4J13W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention