BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 7082791 · Received December 5, 2017

    Report

    Report Number
    1219930-2017-09357
    Event Type
    Malfunction
    Date Received
    December 5, 2017
    Date of Event
    February 14, 2017
    Report Date
    December 5, 2017
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    20884521191010
    PMA / PMN Number
    K133938
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF THE DEVICE. VISUAL AND FUNCTIONAL EVALUATION OF THE RELOAD NOTED A FULLY FIRED CARTRIDGE AND A DEFORMED ANVIL CLAMPING MECHANISM. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS MISUSE OF THE PRODUCT WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. REPLICATION OF THE DEFORMED ANVIL CLAMPING MECHANISM MAY OCCUR UNDER THE FOLLOWING CONDITIONS. 1. APPLICATION OVER TISSUE THAT IS BEYOND THE RECOMMENDED THICKNESS RANGE. 2. APPLICATION WITH AN OBSTACLE INCORPORATED IN THE JAWS. IN ANY OF THESE CIRCUMSTANCES, IT WILL BECOME INCREASINGLY DIFFICULT TO ACTUATE THE FIRING HANDLE AND THE INSTRUMENT RETURN KNOBS WILL BE DIFFICULT TO RETRACT. IN ADDITION, STAPLES MAY NOT FORM PROPERLY AND TISSUE MAY NOT BE FULLY TRANSECTED. THE INFORMATION BOOKLET WHICH ACCOMPANIES EACH PRODUCT SHIPMENT OFFERS THE FOLLOWING AS A WARNING AND PRECAUTION. "1. PREOPERATIVE RADIOTHERAPY MAY RESULT IN CHANGES TO TISSUE. THESE CHANGES MAY, FOR EXAMPLE, CAUSE THE TISSUE THICKNESS TO EXCEED THE INDICATED RANGE THICKNESS FOR THE STAPLE SIZE. CAREFUL CONSIDERATION SHOULD BE GIVEN TO ANY PRE-SURGICAL TREATMENT THE PATIENT MAY HAVE UNDERGONE AND IN CORRESPONDING SELECTION OF STAPLE SIZE. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE 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 LOWER ANTERIOR RESECTIONING WHILE ATTEMPTING TO FIRE OVER VERY THICK TISSUE, THE BUTTRESS MATERIAL DETACHED FROM BOTH RELOADS. THE RELOADS WERE DIPPED IN SALINE PRIOR TO USE. IN ORDER TO COMPLETE THE PROCEDURE, ANOTHER DEVICE WAS USED. THE THIRD RELOAD FIRED SLOWLY OVER THE TISSUE AND STOPPED HALFWAY THROUGH. THE SURGEON RE-FIRED THREE TIMES, AND THE FIRING WAS ABLE TO BE COMPLETED. NO PATIENT INJURY OR EXTENSION IN SURGICAL TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861797 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN EGIATRS60AMT N6D0948KX 20884521191010

    Patients

    Seq Age Sex Outcome Treatment
    1