BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE

    MDR report key: 298097 · Received September 25, 2000

    Report

    Report Number
    1527736-2000-04567
    Event Type
    Malfunction
    Date Received
    September 25, 2000
    Date of Event
    September 1, 2000
    Report Date
    September 5, 2000
    Manufacturer
    ETHICON ENDO-SURGERY - ALB
    Product Code
    LFL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE LCSC5 WAS USED DURING A LAPAROSCOPIC SPLENECTOMY. IT WAS REPORTED BY THE REP THAT THE LCSC5 BLADE NEVER WORKED FROM THE START AND A STEADY TONE WAS REC'D. IT WAS REPORTED THAT IT WAS REPLACED AND THE REPLACEMENT WORKED FINE. THERE WAS NO PT CONSEQUENCE.

    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 N4HX2N

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other