BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE

    MDR report key: 303799 · Received November 7, 2000

    Report

    Report Number
    1527736-2000-05560
    Event Type
    Injury
    Date Received
    November 7, 2000
    Date of Event
    October 13, 2000
    Report Date
    October 13, 2000
    Manufacturer
    ETHICON ENDO-SURGERY - ALB
    Product Code
    LFL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (2) LCSC5 WERE USED DURING A LAP COLECTOMY PROCEDURE. IT WAS REPORTED BY THE REP THAT THE FIRST SHEAR LOCKED OUT 3/4 THRU CASE. THE SECOND SHEAR LOCKED OUT IN THIRTY SECONDS. THERE WAS EXTENDED OR TIME AND HOSP STAY FOR THE PT. 10/20/2000 IT WAS REPORTED BY THE REP THERE WAS BLEEDING DURING THE CASE BECAUSE THE LCSC5 WAS NOT RESPONDING AND AS A RESULT, THE CASE WAS CONVERTED TO OPEN.

    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 N4JX3R

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention