BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TS FLEX ARTICNG LNR CUTR 45MM

    MDR report key: 1170366 · Received September 12, 2008

    Report

    Report Number
    3005075853-2008-01670
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 22, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DAMAGED FIRING TRIGGER TEETH. EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE INSTRUMENT WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE PRESENT. NO FUNCTIONAL TEST COULD BE PERFORMED WITH THE INSTRUMENT AS THE FIRING MECHANISM WAS NOTED TO BE DAMAGED. THE INSTRUMENT WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS, AND THE FIRING TRIGGER TEETH, AND THE LEFT SHROUD PINION AXLE SUPPORT WERE FOUND DAMAGED. EVENT DESCRIPTION COULD NOT BE CONFIRMED AS NO CARTRIDGE WAS RECEIVED FOR ANALYSIS. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATION. THE MANUFACTURING RECORDS WERE REVIEWED, AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY. THE DEVICE WAS FIRED, IT MADE A CRACKING SOUND AND ONLY HALF OF THE STAPLES WERE FIRED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TS FLEX ARTICNG LNR CUTR 45MM GDW ETHICON ENDO-SURGERY, LLC. NA E4L752

    Patients

    Seq Age Sex Outcome Treatment
    1