BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE

    MDR report key: 308846 · Received December 13, 2000

    Report

    Report Number
    1527736-2000-06320
    Event Type
    Injury
    Date Received
    December 13, 2000
    Date of Event
    November 16, 2000
    Report Date
    November 21, 2000
    Manufacturer
    ETHICON ENDO-SURGERY - ALB
    Product Code
    LFL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (1) LCSC5 WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. IT WAS REPORTED BY THE REP THAT DURING THE DOME DOWN LAP CHOLE, THE SURGEON WAS USING THE LCSC5 TO TRANSECT THE CYSTIC ARTERY, AT WHICH TIME THE LCSC5 "LOCKED OUT". IN TRYING TO REESTABLISH A PROPERLY OPERATING BLADE, THE SURGEON NOTICED THAT A TEAR IN THE HEPATIC ARTERY HAD OCCURRED. THE HEMOSTASIS COULD NOT BE ATTAINED THROUGH LAPAROSCOPICALLY, SO THE SURGICAL STAFF CONVERTED THE LAP CHOLE TO AN OPEN CHOLE. ONCE THE LAPAROTOMY WAS MADE, HEMOSTASIS WAS ATTAINED. THE CASE WAS COMPLETED THROUGH THE TRADITIONAL OPEN CHOLE TECHNIQUE.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention