BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE

    MDR report key: 298105 · Received September 26, 2000

    Report

    Report Number
    1527736-2000-04625
    Event Type
    Malfunction
    Date Received
    September 26, 2000
    Date of Event
    August 28, 2000
    Report Date
    August 28, 2000
    Manufacturer
    ETHICON ENDO-SURGERY - ALB
    Product Code
    LFL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THAT THE SURGEON WAS DOING A DOME DOWN LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE WITH THE LCSC5. THE INSTRUMENT BEGAN TO LOCK UP AFTER ABOUT ONE HALF OF THE GALLBLADDER WAS TAKEN OFF LIVER. THE LOCK UP SEEMED TO OCCUR AFTER THE LCSC5 CAME INTO CONTACT WITH A METAL TIP GRASPER. A NEW LCSC5 WAS OPENED AND THE CASE CONTINUED ON VERY WELL WITH NO PT CONSEQUENCE.

    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 N4H873

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other