BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 6805487 · Received August 18, 2017

    Report

    Report Number
    1219930-2017-06525
    Event Type
    Malfunction
    Date Received
    August 18, 2017
    Date of Event
    July 12, 2017
    Report Date
    November 9, 2017
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    PMA / PMN Number
    K121510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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 AND FUNCTIONAL EVALUATION OF THE ADAPTER NOTED NO ABNORMALITIES. EVALUATION OF THE EEPROM NOTED THAT THE CODE DRIVE_MOTOR_EXCESSIVE_LOAD_MODE WAS PRESENT. THIS WAS INDICATIVE OF A THICK TISSUE APPLICATION AND COULD CONFIRM THE REPORTED CONDITION. VISUAL AND FUNCTIONAL TESTING OF THE RETURNED PRODUCT CONFIRMED THE PRODUCT, AS RECEIVED, MET RELEASE SPECIFICATIONS. PRODUCT ANALYSIS SUGGESTS THE PRODUCT WAS USED IN A SURGICAL PROCEDURE. 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 DRIVE_MOTOR_EXCESSIVE_LOAD_MODE ERROR CODES MAY OCCUR OF THE DEVICE STOPS FIRING BEFORE THE LOWER CLAMP REACHES THE DISTAL END, WHICH IS LIKELY DUE TO THE FIRING FORCE REACHING THE UPPER DESIGN LIMIT OF THE ENDO GIA RELOAD. THIS 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 EITHER SCENARIO, STAPLES MAY NOT FORM PROPERLY AND TISSUE MAY NOT BE FULLY TRANSECTED. 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 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: PER ADDITIONAL INFORMATION RECEIVED OCCURRED DURING A ROBOTIC SLEEVE GASTRECTOMY ( LAPAROSCOPIC PROCEDURE). TWO POWERED HANDLE DEVICES LOCKED ONTO TISSUE. MANUAL HANDLE WAS USED IN ORDER TO COMPLETE THE CASE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC PROCEDURE. TWO POWERED HANDLE DEVICES LOCKED ONTO TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583708 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN EGIAADAPTXL

    Patients

    Seq Age Sex Outcome Treatment
    1