BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL LAPAROSCOPIC COAGULATING SHEARS, KNI

    MDR report key: 278392 · Received May 18, 2000

    Report

    Report Number
    1527736-2000-02143
    Event Type
    Injury
    Date Received
    May 18, 2000
    Date of Event
    April 22, 2000
    Report Date
    May 1, 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
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THAT (1) LCSK5 WAS USED DURING A LAPAROSCOPIC SPLENECTOMY PROCEDURE. IT WAS REPORTED THAT THE TROCAR SITE WHERE THE LCSK5 WAS BEING USED CAUSED A SKIN BURN TO THE PT. THE SURGEON TORQUED THE PORT UPWARD TO THE ANTERIOR ABDOMINAL WALL AND THE HEAT TRANSFER TO THE TROCAR CANNULA CAUSED A SECOND DEGREE BURN.

    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 Required Intervention