BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL LAPAROSONIC COAGULATING SHEARS, KNI

    MDR report key: 221567 · Received May 3, 1999

    Report

    Report Number
    1527736-1999-02621
    Event Type
    Injury
    Date Received
    May 3, 1999
    Date of Event
    April 7, 1999
    Report Date
    April 7, 1999
    Manufacturer
    ETHICON ENDO-SURGERY ALB
    Product Code
    LFL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THE DEVICE WAS USED DURING A LAPAROSCOPIC NISSEN PROCEDURE. IT WAS REPORTED WHILE TAKING DOWN THE SHORT GASTRIC ARTERIES WITH THE 5MM LCS HARMONIC SCALPEL, DR ENCOUNTERED BLEEDING THAT COULD NOT BE CONTROLLED LAPAROSCOPICALLY. HE WAS WORKING AT THE SHORT GASTRIC AT THE BASE OF THE SPLEEN WITH THE VARIABLE SETTING AT FOUR. DR WAS USING THE 5MM LCS FOR THE FIRST TIME BUT HAD USED THE 10MM LCS ON MANY OCCASIONS. HE MADE THE DECISION TO CONVERT TO OPEN AND THE NISSEN FUNDOPLICATION WAS COMPLETED. THE HOSP STAY WAS EXTENDED BY 5 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC SCALPEL LAPAROSONIC COAGULATING SHEARS, KNI ULTRASONIC-SURGERY DEVICES - ENDOSC LFL ETHICON ENDO-SURGERY ALB NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention