BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIA

    MDR report key: 7637673 · Received June 26, 2018

    Report

    Report Number
    2647580-2018-03149
    Event Type
    Malfunction
    Date Received
    June 26, 2018
    Date of Event
    June 8, 2018
    Report Date
    October 4, 2018
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    UDI-DI
    10884523007220
    PMA / PMN Number
    K111825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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

    ADDITIONAL: EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE WITH SINGLE USE LOADING UNIT. VISUAL INSPECTION NOTED THE SINGLE USE LOADING UNIT (SULU) WAS RECEIVED PARTIALLY APPLIED WITH THE INTERLOCK ENGAGED. MICROSCOPIC INSPECTION OF THE KNIFE BLADE DISPLAYED NO DAMAGE. THE SINGLE USE LOADING UNIT (SULU) WAS LOADED INTO A TEST DEVICE. THE SINGLE USE LOADING UNIT (SULU) AND INSTRUMENT WERE APPLIED TO TEST MEDIA WITH ACCEPTABLE RESULTS. 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 REPORTED CONDITION MAY OCCUR IF THE FIRING STROKE IS NOT COMPLETE AND THE FIRING KNOB IS NOT FULLY RETRACTED AFTER FIRING OR IF THE INSTRUMENT IS APPLIED AGAINST AN EXCESSIVE AMOUNT OF TISSUE DURING THE CLINICAL APPLICATION. IF THE FIRING KNOB IS NOT FULLY RETRACTED, DIFFICULTY IN UNLOADING THE LOADING UNIT MAY BE EXPERIENCED, AND MAY PREVENT FURTHER LOADING FROM OCCURRING. THE INSTRUCTIONS FOR USE (IFU) STATES THAT TO REMOVE THE SINGLE USE LOADING UNIT (SULU), SEPARATE THE INSTRUMENT HALVES. HOLDING THE CARTRIDGE-HALF OF THE INSTRUMENT, GRASP THE PROXIMAL END OF THE SINGLE USE LOADING UNIT (SULU) TABS AND PULL UP AND OUT TO REMOVE THE SINGLE USE LOADING UNIT (SULU) FROM THE INSTRUMENT. TO PLACE A NEW SINGLE USE LOADING UNIT (SULU) INTO THE INSTRUMENT, HOLD THE SINGLE USE LOADING UNIT (SULU) BY THE PROXIMAL END TABS AND INSERT INTO THE CARTRIDGE FORK AT A 30 TO 45 DEGREE ANGLE FROM THE DISTAL END DOWN UNTIL THE UNIT SNAPS INTO PLACE. REMOVE SHIPPING WEDGE AFTER SINGLE USE LOADING UNIT (SULU) IS FULLY LOADED. SINGLE USE LOADING UNIT (SULU) WILL ¿FLOAT¿ UP AND DOWN IN FINAL LOADED POSITION. 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, IN ESOPHAGECTOMY PROCEDURE, HE WAS ABOUT TO FIRE THE DEVICE, BUT FOUND THAT THE KNIFE BLADE ON THE RELOAD WOULD NOT BE PUSHED OUT. THE SURGEON THEN USED ANOTHER RELOAD AND FOUND THE KNIFE BLADE WAS SMOOTH TO PUSH NOW AND WAS ABLE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482155 GIA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO GIA6038L P7C1110X 10884523007220

    Patients

    Seq Age Sex Outcome Treatment
    1