BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALPEL ULTRACISION LAPROSCONIC COAGULATING SHE

    MDR report key: 286297 · Received July 17, 2000

    Report

    Report Number
    1527736-2000-03174
    Event Type
    Malfunction
    Date Received
    July 17, 2000
    Report Date
    June 26, 2000
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    LFL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THAT THE (1) LCSC5 WAS USED DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION PROCEDURE. IT WAS REPORTED THAT THE TISSUE PAD FELL INTO THE ABDOMINAL CAVITY OF THE PATIENT AFTER INSERTING THE LCSC5 THROUGH A 10/11MM TROCAR. THE PAD WAS FOUND AND IMMEDIATELY REMOVED. A SECOND INSTRUMENT WAS OPENED AND USED TO COMPLETE THE CASE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC SCALPEL ULTRACISION LAPROSCONIC COAGULATING SHE ULTRASONIC-SURGERY DEVICES-ENDOSC LFL ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other