BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL LAPAROSCOPIC COAGULATING SHEARS, KNI

    MDR report key: 272124 · Received April 3, 2000

    Report

    Report Number
    1527736-2000-01292
    Event Type
    Injury
    Date Received
    April 3, 2000
    Date of Event
    March 17, 2000
    Report Date
    March 17, 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 BY THE REP THAT (1) LCSK5 WAS USED DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION PROCEDURE. IT WAS REPORTED THAT AFTER GAINING ACCESS TO THE ABDOMEN THE SURGEON BEGAN DISSECTION THROUGH THE HEPATO GASTRIC LIGAMENT UTILIZING A GRASPER AND AN LCSK5. THE SURGEON ENCOUNTERED BLEEDING ALONG THE LEFT LOBE OF THE LIVER NEAR THE CORONARY LIGAMENT. THE SURGEON ATTEMPTED TO CONTROL THE BLEEDING WITH THE LCS TO NO AVAIL. BLOOD INCREASED IN VOLUME. THE ANESTHETIST REQUESTED THE SURGEON TO STOP. THE CASE WAS CONVERTED TO OPEN. UPON OPENING, THE ABDOMEN WAS FILLED WITH 1500 CC OF BLOOD. THE SURGEON WAS UNABLE TO DETERMINE THE SOURCE. THE SURGEON WAS JOINED BY A THORACIC SURGEON WHO PERFORMED A RIGHT THORACOTOMY AND WAS ABLE TO CONTROL THE BLEEDING. THE PT RECEIVED 49 UNITS OF BLOOD. THE OPERATING ROOM TIME WAS EXTENDED BY (4) HOURS. 3/29/2000 RECEIVED MESSAGE FROM SALES REP. REP SPOKE WITH DR WHO INDICATED THERE WAS NO ISSUE WITH THE HARMONIC SCALPEL DEVICE. PHYSICIAN ENCOUNTERED AN ANOMALOUS CORONARY VEIN DURING THE PROCEDURE. DUE TO THE CARBON DIOXIDE PRESSURE IN THE ABDOMEN, THE PT DEVELOPED A CARBON DIOXIDE EMBOLUS WHEN THE VEIN WAS TRANSECTED. THE PT THEN ARRESTED ALMOST IMMEDIATELY AND WAS CONVERTED TO OPEN. CURRENTLY, THE PT HAS BEEN EXTUBATED AND IS IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC SCALPEL LAPAROSCOPIC COAGULATING SHEARS, KNI ULTRASONIC-SURGERY DEVICES - ENDOSC LFL ETHICON ENDO-SURGERY - ALB NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other