BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE

    MDR report key: 286055 · Received July 14, 2000

    Report

    Report Number
    1527736-2000-03140
    Event Type
    Malfunction
    Date Received
    July 14, 2000
    Date of Event
    June 20, 2000
    Report Date
    June 21, 2000
    Manufacturer
    ETHICON ENDO-SURGERY - ALB
    Product Code
    LFL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (1) LCSC5 WAS USED DURING A LAVH PROCEDURE. IT WAS REPORTED BY THE REP THAT THE SURGEON WAS USING THE LCSC5 AND THE BLADE WOULD NOT CUT AND COAGULATE FOR TWO OR THREE SECONDS BEFORE GIVING A SOLID TONE. CONSIDERABLE BLEEDING OCCURRED AND THE SURGEON HAD TO OPEN A ATW35 TO CONTROL THE BLEEDING. THE CASE WAS COMPLETED WITHOUT ANY OTHER INCIDENT. 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 N4HM9K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other