BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA ULTRA

    MDR report key: 7448991 · Received April 20, 2018

    Report

    Report Number
    2647580-2018-01991
    Event Type
    Malfunction
    Date Received
    April 20, 2018
    Date of Event
    March 30, 2018
    Report Date
    June 26, 2018
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    UDI-DI
    20884523003540
    PMA / PMN Number
    K111825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. INITIAL VISUAL INSPECTION OF THE INSTRUMENT NOTED NO ABNORMALITIES. FUNCTIONALLY, THE INSTRUMENT WAS LOADED WITH A PMV REPRESENTATIVE DEVICE RELOAD. DURING TESTING OF THE INSTRUMENT, A SKIP WAS NOTED IN THE UNITS FIRING STROKE AFTER CLOSURE OF THE LOADING UNIT 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 AT SITE OF INITIAL FIRING POST CLAMP UP. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THE PRODUCT WAS 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, FIRING OVER TISSUE THAT IS BEYOND THE RECOMMENDED THICKNESS RANGE, 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, 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 MISUSE OF THE PRODUCT WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. 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.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A VIDEO ASSISTED THORACIC LOBECTOMY, THE STAPLER WAS ABLE TO FIRE BUT AT THE THIRD FEEDER, IT JAMMED ON THE LOBAR BRONCHUS. THE STAPLER WAS TESTED AND SEEING THAT IT STOPPED RESPONDING, IT WAS IMMEDIATELY CHANGED WITH ANOTHER DEVICE. THE INSTRUMENT COULD BE REOPENED BUT THE STAPLER WAS BLOCKED DURING STAPLING OF THE BRONCHUS. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290993 ENDO GIA ULTRA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO EGIAUSTND P7K1002X 20884523003540

    Patients

    Seq Age Sex Outcome Treatment
    1