BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE

    MDR report key: 287544 · Received July 26, 2000

    Report

    Report Number
    1527736-2000-03328
    Event Type
    Injury
    Date Received
    July 26, 2000
    Date of Event
    June 27, 2000
    Report Date
    June 29, 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) DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED BY THE REP THAT THE LCSC5 WAS USED TO PERFORM A DOME DOWN LAP CHOLE IN 2000. THE CASE ENDED NICELY AND THE PT DID FINE. IT SEEMED TO BE A QUICK CASE AS THE SURGEON PLACED CLIPS ON THE CYSTIC DUCT AND ARTERY. AFTER GALLBLADDER WAS REMOVED, THE SURGEON IRRIGATED AND FINISHED THE CASE. IT SEEMED TO BE A ROUTINE CASE, THEN 6 HOURS POSTOP THE PT WENT INTO CARDIAC ARREST. IT WAS REPORTED BY THE OR NURSES THE HOSP IS NOT BLAMING THE INSTRUMENT, HOWEVER, THE NEW APPROACH AND THE POST-OP PROBLEM WERE LINKED TOGETHER. REP BELIEVES THIS PT IS DOING BETTER AND ON THE WAY TO A FULL RECOVERY. IT WAS REPORTED, THAT THE PT HAD HEART ATTACK AFTER THE PROCEDURE. IT WAS REPORTED THE SURGEON THOUGHT THE PNEUMOPERITONEUM MAY HAVE CONTRIBUTED TO THE PT'S HEART ATTACK AND THAT IT WAS PROBABLY COMING ANYWAY.

    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