BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 6990205 · Received October 31, 2017

    Report

    Report Number
    1219930-2017-08394
    Event Type
    Malfunction
    Date Received
    October 31, 2017
    Date of Event
    September 29, 2017
    Report Date
    January 2, 2018
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    10884523003154
    PMA / PMN Number
    K111825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE VISUAL INSPECTION OF THE RETURNED PRODUCT NOTED THAT THE RELOAD WAS PARTIALLY FIRED TO THE 2CM CUT LINE. SUB-FLUSH STAPLE PUSHERS WERE NOTED FROM THE 45CM CUT LINE TO THE 2CM CUT LINE. THE CLAMPING MECHANISM WAS DEFORMED. THE ANVIL IS SLIGHTLY BOWED, AND THE LASER WELD HAS FAILED NEAR THE TISSUE STOP. FUNCTIONALLY THE RELOAD WAS LOADED INTO A POST MARKET VIGILANCE INSTRUMENT, THE INTERLOCK WAS OVERRIDDEN, AND THE RELOAD WAS APPLIED TO TEST MEDIA. ALL STAPLES WERE PLACED AND TEST MEDIA WAS CLEANLY TRANSECTED. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. REPLICATION OF THE BOWED ANVIL, DEFORMED ANVIL CLAMPING MECHANISM, AND SUB-FLUSH STAPLE PUSHERS MAY OCCUR UNDER THE FOLLOWING CONDITIONS: APPLICATION OVER TISSUE THAT IS BEYOND THE RECOMMENDED THICKNESS RANGE; 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. "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: OCCURRED DURING A PROCEDURE. THERE WAS A LOUD CRACKING SOUND AND IT DID NOT STAPLE. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO MEDICAL INTERVENTION REQUIRED AND NO PATIENT INJURY.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: PER ADDITIONAL INFORMATION RECEIVED OCCURRED DURING A ROBOTIC PROSTATECTOMY PROCEDURE. SURGEON RESORTED TO SUTURING IN ORDER TO COMPLETE THE CASE. EXACT DELAY WAS NOT CALCULATED BUT A SIGNIFICANT DELAY IN SURGICAL TIME WAS EXPERIENCED. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769377 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN EGIA45AMT N7D0681KX 10884523003154

    Patients

    Seq Age Sex Outcome Treatment
    1