BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 4130339 · Received September 30, 2014

    Report

    Report Number
    1717344-2014-00675
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 7, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT : 08/01/2014. DATE OF FOLLOW-UP REPORT : 09/30/2014. THE CLEAR INSULATION WAS DAMAGED. THE DEVICE FAILED HIPOT TESTING. THE IFU STATES TO PREVENT DAMAGE TO THE FLEXIBLE INSULATION PROXIMAL TO THE JAWS, CONFIRM THE HANDLE IS FULLY CLOSED PRIOR TO INSERTION INTO AND EXTRACTION FROM THE CANNULA. USE THE APPROPRIATELY SIZED CANNULA TO ALLOW FOR EASY INSERTION AND EXTRACTION OF THE INSTRUMENT. FAILURE TO DO SO MAY IMPACT THE INTEGRITY OF THE FLEXIBLE INSULATION. CANNULAS WITH HARD, NON-BEVELED OPENINGS MAY CAUSE THE FLEXIBLE INSULATION TO RETRACT, WHICH MAY COMPROMISE THE INSULATION. IF RETRACTION OCCURS, THE INSTRUMENT MUST BE DISCARDED. DO NOT ATTEMPT TO CLEAN THE FLEXIBLE INSULATION. CLEANING MAY DAMAGE INSULATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A LAPAROSCOPIC NEPHRECTOMY, THE INSULATION AROUND THE JAWS WAS BUNCHING UP WHILE IN USE. THERE WAS NO PT INJURY. ANOTHER DEVICE OF THE SAME TYPE WAS OPENED AND USED TO CONTINUE THE PROCEDURE.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO COVIDIEN AND VISUAL INSPECTION DISCOVERED THAT A PORTION OF THE CLEAR INSULATION WAS MISSING. THE SITE CONFIRMED THAT THE PORTION OF CLEAR INSULATION WAS REMOVED BY THE SURGEON AND NOTHING FELL INTO THE PATIENT CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607971 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 32760245X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK