BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIFIRE ENDO GIA

    MDR report key: 6922035 · Received October 6, 2017

    Report

    Report Number
    2647580-2017-07037
    Event Type
    Malfunction
    Date Received
    October 6, 2017
    Date of Event
    April 2, 2017
    Report Date
    June 1, 2017
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    UDI-DI
    10884523003765
    PMA / PMN Number
    K900129
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF THE DEVICE. THE VISUAL INSPECTION AND FUNCTIONAL EVALUATION OF THE DEVICE HAD ACCEPTABLE RESULTS. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. ANALYSIS CONCLUDED THERE WERE NO ASSEMBLY COMPONENT RELATED FAILURES. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY AMENDED AS APPROPRIATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: DURING A LAPAROSCOPIC APPENDECTOMY, THE SCRUB TECH COULD NOT REMOVE THE DEVICE LOADING UNIT FROM THE INSTRUMENT. THE SURGEON WAS NOT ABLE TO SQUEEZE THE HANDLE OR FIRE THE DEVICE. ANOTHER MULTIFIRE ENDO GIA 30 2.5 WAS USED TO COMPLETE THE SURGERY. THERE WAS NO INJURY TO THE PATIENT OR ADDITIONAL MEDICAL OR SURGICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703076 MULTIFIRE ENDO GIA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO 030805L UNKNOWN 10884523003765

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR