BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA ULTRA

    MDR report key: 6929932 · Received October 9, 2017

    Report

    Report Number
    1219930-2017-07847
    Event Type
    Malfunction
    Date Received
    October 9, 2017
    Date of Event
    September 14, 2017
    Report Date
    January 26, 2018
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    UDI-DI
    10884523003147
    PMA / PMN Number
    K111825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    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. DURING THE FIRING CYCLE, A SKIP WAS AUDIBLE IN THE FIRING STROKE. AN ACCESS HOLE WAS CUT INTO THE INSTRUMENT BODY FOR VISUALIZATION OF THE FIRING RACK. THIS EXAMINATION NOTED SHEARED TEETH ON THE FIRING RACK. 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. 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, OCCURRED DURING A PULMONARY LOBECTOMY VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) PROCEDURE. THE STAPLING DEVICE WAS BEING APPLIED TO 'COUPE DE LA VEINE'. THE STAPLER WAS ABLE TO FIRE BUT THERE WAS POOR STAPLE FORMATION. THERE WERE ABSENT CLIPS ON ONE STAPLE TRAY. THE STAPLE LINE WAS INCOMPLETE. THE SURGICAL TIME WAS EXTENDED BY THIRTY MINUTES OR MORE DUE TO THE PRODUCT PROBLEM. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, USED CLIPS. THE PATIENT OUTCOME IS ALIVE, NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711131 ENDO GIA ULTRA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO EGIAUSHORT P4M0159X 10884523003147

    Patients

    Seq Age Sex Outcome Treatment
    1