BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 7036420 · Received November 16, 2017

    Report

    Report Number
    1219930-2017-08803
    Event Type
    Malfunction
    Date Received
    November 16, 2017
    Date of Event
    October 25, 2017
    Report Date
    January 12, 2018
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    20884523003175
    PMA / PMN Number
    K111825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF SEVEN DEVICES. VISUAL INSPECTION OF THE FIRST, SECOND, AND THIRD RETURNED PRODUCTS NOTED THAT THE FIRST THREE RELOADS WERE FULLY FIRED. THE FIRST RELOAD HAD DAMAGE TO THE CUTTING EDGE OF THE KNIFE BLADE AND FLUSH STAPLE PUSHERS. THE SECOND RELOAD HAD A DEFORMED CLAMPING MECHANISM AND FLUSH STAPLE PUSHERS. THE THIRD RELOAD DAMAGE TO THE CUTTING EDGE OF THE KNIFE BLADE AND FLUSH STAPLE PUSHERS. THE FOURTH RELOAD WAS PARTIALLY FIRED TO THE 3CM CUT LINE, HAD A DEFORMED CLAMPING MECHANISM, AND FLUSH STAPLE PUSHERS. THE FIFTH RELOAD WAS PARTIALLY FIRED TO THE 3CM CUT LINE. THE SIXTH RELOAD WAS PARTIALLY FIRED TO THE 1CM CUT LINE, HAD DAMAGE TO THE CUTTING EDGE OF THE KNIFE BLADE, FLUSH PUSHERS, AND THE LASER WELD HAD FAILED NEAR THE TISSUE STOP. THE SEVENTH RELOAD WAS PARTIALLY FIRED TO THE 4CM CUT LINE, HAD A BENT ARTICULATION FLAG, AND THE ADAPTER WAS BROKEN. FUNCTIONALLY THE RELOADS WERE LOADED INTO A POST MARKET VIGILANCE INSTRUMENT. THE FIRST, SECOND, AND THIRD RELOAD WERE CYCLED WITHOUT HESITATION OR BINDING. THE INTERLOCKS OF THE FOURTH, FIFTH, AND SIXTH RELOADS WERE OVERRIDDEN AND THE RELOADS WERE APPLIED TO TEST MEDIA. ALL REMAINING STAPLES WERE PLACED AND TEST MEDIA WAS CLEANLY TRANSECTED. FUNCTIONAL TESTING OF THE SEVENTH RELOAD COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RELOAD. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. 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 DAMAGED KNIFE BLADE MAY OCCUR WHEN AN OBSTACLE HAS BEEN INCORPORATED IN THE JAWS DURING APPLICATION. THE INFORMATION BOOKLET WHICH ACCOMPANIES EACH PRODUCT SHIPMENT CAUTIONS THE USER; ENSURE THAT NO OBSTRUCTIONS ARE INCORPORATED IN THE INSTRUMENT JAWS. FIRING OVER AN OBSTRUCTION MAY RESULT IN INCOMPLETE CUTTING ACTION AND/OR IMPROPERLY FORMED STAPLES. REPLICATION OF THE CLAMPING MECHANISM DEFORMATION AND ANVIL BOWING MAY OCCUR THROUGH MANIPULATION OF TISSUE USING THE ANVIL SIDE OF THE LOADING UNIT, OR CLAMPING OVER EXCESSIVE THICKNESS. REPLICATION OF THE DAMAGED RELOAD ADAPTER MAY OCCUR DUE TO OVER FLEXURE OF THE RELOAD WHILE ATTACHED TO THE INSTRUMENT. REPLICATION OF THE BENT ARTICULATION FLAG CONDITION CAN OCCUR IF THE LOADING UNIT IS FORCEFULLY ROTATED WHILE ONLY PARTIALLY INSERTED INTO THE INSTRUMENT SHAFT OR IF TRYING TO REMOVE LOADING UNIT WITHOUT ARTICULATION LEVER BEING IN NEUTRAL POSITION. 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: DURING A LAPAROSCOPIC ESOPHAGECTOMY PROCEDURE, THE STAPLING DEVICE WAS BEING USED FOR CREATING THE SLEEVE. THE STAPLER WAS NOT ABLE TO FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WAS NOT ABLE TO SQUEEZE THE HANDLE. THE BACK OF THE RELOAD BROKE OFF BUT DID NOT FALL INTO THE CAVITY OF THE PATIENT. THE STAPLE LINE WAS INCOMPLETE AT THE PROXIMAL END. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, THEY HAD TO SWITCH TO A NEW STAPLING HANDLE AND RELOAD. THIS LED TO AN EXTENSION OF THE SURGICAL TIME BY THIRTY MINUTES OR MORE. THERE WAS NO PATIENT HARM. THE PATIENT OUTCOME IS ALIVE, NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819081 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN EGIA45AVM N7C0285KX 20884523003175

    Patients

    Seq Age Sex Outcome Treatment
    1