BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE

    MDR report key: 288403 · Received August 2, 2000

    Report

    Report Number
    1527736-2000-03483
    Event Type
    Malfunction
    Date Received
    August 2, 2000
    Report Date
    July 13, 2000
    Manufacturer
    ETHICON ENDO-SURGERY - ALB
    Product Code
    LFL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (1) LCSC5 WAS USED DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE. IT WAS REPORTED BY THE REP THAT THE TISSUE PAD FELL OFF INSTRUMENT INSIDE PT DURING CASE AND WAS REMOVED. THE CASE WAS COMPLETED WITH ANOTHER LCSC5 THERE WAS NO CONSEQUENCE TO PT.

    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