BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE

    MDR report key: 285055 · Received July 10, 2000

    Report

    Report Number
    1527736-2000-03035
    Event Type
    Injury
    Date Received
    July 10, 2000
    Date of Event
    June 2, 2000
    Report Date
    June 12, 2000
    Manufacturer
    ETHICON ENDO-SURGERY - ALB
    Product Code
    LFL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THAT THE (1) LCSC5 WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. IT WAS REPORTED THAT THE SURGEON WAS USING A "DOME-DOWN TECHNIQUE" UTILIZING THE HARMONIC SCALPEL LAPAROSCOPIC CURVED SHEARS. THE SURGEON DISSECTED THE ENTIRE GALLBLADDER FROM THE LIVER BED. WHEN DISSECTING THE TRIANGLE OF CALOT, THE SURGEON ENCOUNTERED AN ATYPICAL ANATOMY INCLUDING A VERY SHORT CYSTIC DUCT AND AN ACCESSORY BILE DUCT OF SOME ORIGIN THAT RAN PARALLEL TO A STRUCTURE BELIEVED TO BE THE COMMON BILE DUCT. THIS ACCESSORY DUCT WAS TRANSECTED WITH THE HARMONIC SCALPEL (PRIOR TO ITS IDENTIFICATION AS SUCH). THE STRUCTURE BELIEVED TO BE THE COMMON BILE DUCT WAS EXAMINED CLOSELY WITH NO EVIDENCE OF INJURY OF ANY KIND. THE SMALL BILIARY VESSEL WAS CLIPPED. THE INTROP CHOLANGIOGRAM WAS INCONCLUSIVE SHOWING DISTAL FLOW, BUT LITTLE RETROGRADE. SEVERAL DAYS LATER, THE PT BECAME ILL. IT WAS DISCOVERED THAT THE MID-COMMON BILE DUCT HAD RECEIVED A HEAT GENERATED TRANSECTION, APPARENTLY FROM THE HARMONIC SCALPEL. THE CONDITION OF THE PT IS UNKNOWN AT THIS TIME.

    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