BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL LAPAROSCOPIC COAGULATING SHEARS, KNI

    MDR report key: 273278 · Received April 11, 2000

    Report

    Report Number
    1527736-2000-01425
    Event Type
    Injury
    Date Received
    April 11, 2000
    Report Date
    March 13, 2000
    Manufacturer
    ETHICON ENDO-SURGERY-ALB
    Product Code
    LFL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THAT THE (1) LCSK5 WAS USED DURING A LAPAROSCOPIC NISSEN PROCEDURE. IT WAS REPORTED THAT THE SURGEON HAD TO PERFORM A RE-OPERATION DUE TO "BOILING" OF TISSUE. THE SURGEON FELT THE TISSUE WAS MORE BOILED THAN MD WAS USED TO. THE PT'S CURVATURE OF THE STOMACH WAS SEVERELY NECROSSED AND THERE WERE BURN MARKS ALONG THE SAME AREA. 03/17/2000 THE SURGEON WAS PERFORMING BACK SIDE CUTTING WITH THE CLAMP ARM DOWN. MD HAD JUST STARTED USING THE 5MM BLADES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention