BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE

    MDR report key: 298167 · Received September 25, 2000

    Report

    Report Number
    1527736-2000-04566
    Event Type
    Malfunction
    Date Received
    September 25, 2000
    Date of Event
    August 30, 2000
    Report Date
    August 31, 2000
    Manufacturer
    ETHICON ENDO-SURGERY - ALB
    Product Code
    LFL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (1) LCSC5 WAS USED DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY PROCEDURE. IT WAS REPORTED BY THE REP THAT THE SOLID TONE WAS HEARD FROM THE HARMONIC SCALPEL. THE BLADE WAS REMOVED FROM THE HANDPIECE. A SECOND INSTRUMENT WAS OPENED AND USED TO COMPLETE THE CASE. 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 N4J306

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other