BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA ULTRA

    MDR report key: 8921700 · Received August 22, 2019

    Report

    Report Number
    2647580-2019-04229
    Event Type
    Malfunction
    Date Received
    August 22, 2019
    Date of Event
    July 8, 2019
    Report Date
    January 2, 2020
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    UDI-DI
    10884523003550
    PMA / PMN Number
    K111825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. INITIAL VISUAL INSPECTION OF THE INSTRUMENT NOTED THAT THE FIRING KNOBS WERE RETRACTED, AND THE ARTICULATION LEVER WAS IN NEUTRAL POSITION. FUNCTIONALLY, THE INSTRUMENT WAS LOADED WITH A REPRESENTATIVE SINGLE USE LOADING UNIT. DURING TESTING OF THE INSTRUMENTS, A SKIP WAS NOTED IN THE UNITS FIRING STROKE AFTER CLOSURE OF THE RELOAD JAWS. AN ACCESS HOLE WAS CUT INTO THE INSTRUMENT BODY FOR VISUALIZATION OF THE FIRING RACK. THIS EXAMINATION NOTED SHEARED TEETH ON THE FIRING RACK. 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 SHEARED TEETH ON THE FIRING RACK MAY OCCUR IN ANY OF THE FOLLOWING CIRCUMSTANCES: 1. FIRING OVER TISSUE THAT IS BEYOND THE RECOMMENDED THICKNESS RANGE. 2. FIRING WITH AN OBSTACLE INCORPORATED IN THE JAWS. IN EITHER 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. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS DUE TO THE PRODUCT NOT BEING USED AS INTENDED WHICH CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. NO FURTHER ACTIONS HAVE BEEN DEEMED NECESSARY AT THIS TIME. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS BEING APPLIED TO THE STOMACH DURING A LAPAROSCOPIC GASTROPLASTY, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT THE STAPLER DID NOT FIRE. IT WAS ALSO STATED THAT THE STAPLER BROKE AFTER THE FIRST SHOT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716000 ENDO GIA ULTRA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO EGIAUXL P7J1219X 10884523003550

    Patients

    Seq Age Sex Outcome Treatment
    1