BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE

    MDR report key: 304425 · Received November 13, 2000

    Report

    Report Number
    1527736-2000-05690
    Event Type
    Injury
    Date Received
    November 13, 2000
    Date of Event
    October 18, 2000
    Report Date
    October 27, 2000
    Manufacturer
    ETHICON ENDO-SURGERY - ALB
    Product Code
    LFL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (1) DEVICE WAS USED DURING A LAPAROSCOPIC SPLENECTOMY. IT WAS REPORTED BY THE REP THAT WHILE USING THE LCSC5 DURING THE CASE, THE SURGEON WAS DISSECTING SHORT GASTRIC, WHEN ACTIVE BLADE OF LCS CAME IN CONTACT WITH SPLENIC ARTERY. THIS CONTACT CAUSED AN OPENING IN THE SPLENIC ARTERY. THE SURGEON DECIDED TO CONVERT TO OPEN TO COMPLETE THE CASE.

    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