BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE

    MDR report key: 289060 · Received August 7, 2000

    Report

    Report Number
    1527736-2000-03568
    Event Type
    Malfunction
    Date Received
    August 7, 2000
    Report Date
    July 12, 2000
    Manufacturer
    ETHICON ENDO-SURGERY - ALB
    Product Code
    LFL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (1) LCSC5 WAS USED DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION PROCEDURE. IT WAS REPORTED BY REP THE MD JUST STARTED TO USE THE INSTRUMENT AND GOT A STRAIGHT TONE. THE BLADE BROKE OFF AND FELL INTO THE ABDOMEN AND WAS RETRIEVED WITHOUT INCIDENT OR CONSEQUENCE TO THE PT. OPENED A NEW LCSC5 AND COMPLETED 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 N4HM2V

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other