BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE

    MDR report key: 297258 · Received September 22, 2000

    Report

    Report Number
    1527736-2000-04543
    Event Type
    Injury
    Date Received
    September 22, 2000
    Date of Event
    August 24, 2000
    Report Date
    August 25, 2000
    Manufacturer
    ETHICON ENDO-SURGERY-ALB
    Product Code
    LFL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (2) DEVICES WERE USED DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION. IT WAS REPORTED BY THE AFFILIATE THAT A CONTINUOUS TONE WAS OMITTED THROUGHOUT THE PROCEDURE WITH THE LCSC5'S. A 45 MINUTE PROCEDURE, BECAME A (3) HOUR OPERATION WHICH RESULTED IN AN INCREASED ANAESTHETIC RISK, A LONGER RECOVERY PERIOD, INCREASED PAIN POSTOP AND HIGHER COST TO THE PT. THE PROCEDURE WAS COMPLETED USING ELECTROCAUTERY. 09/14/2000 AFFILIATE SENT EMAIL. THE RECOVERY TIME WAS 30 MINUTES LONGER IN THE RECOVERY ROOM AND THE PT HAS BEEN DISCHARGED FROM THE HOSP.

    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 33 YR Required Intervention