BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE

    MDR report key: 298208 · Received September 25, 2000

    Report

    Report Number
    1527736-2000-04569
    Event Type
    Malfunction
    Date Received
    September 25, 2000
    Date of Event
    September 5, 2000
    Report Date
    September 7, 2000
    Manufacturer
    ETHICON ENDO-SURGERY - ALB
    Product Code
    LFL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (2) DEVICES WERE USED DURING A LAPAROSCOPIC VENTRAL HERNIA. IT WAS REPORTED BY THE REP THAT THE LCSC5 DID NOT SEEM TO BE CUTTING, THEN THE HP052 SILVER HANDLE ON HANDPIECE GOT REALLY HOT (TOO HOT TO HOLD). REPLACED THE BLADE AND CORD TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other