BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 7050336 · Received November 21, 2017

    Report

    Report Number
    1219930-2017-08991
    Event Type
    Malfunction
    Date Received
    November 21, 2017
    Date of Event
    October 30, 2017
    Report Date
    February 8, 2018
    Manufacturer
    COVIDIEN NORTH HAVEN-MFG
    Product Code
    GDW
    UDI-DI
    30884523003219
    PMA / PMN Number
    K111825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. 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 INSPECTION NOTED THAT THE RELOAD WAS PRE-FIRED AND ENGAGED IN INTERLOCK WITH THE JAWS OPEN. FUNCTIONAL TESTING OF THE RELOAD FOUND NO ABNORMALITIES. 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 PRE-FIRE CONDITION WITH INTERLOCK ENGAGEMENT MAY OCCUR IF THE INSTRUMENT FIRING HANDLE HAD BEEN PARTIALLY COMPRESSED AND RELEASED AFTER PRESSING THE GREEN FIRING BUTTON. IN THIS SITUATION, THE SAFETY INTERLOCK FEATURE WILL ENGAGE AND PREVENT THE RELOAD FROM FIRING A SECOND TIME BY CEASING THE PLACEMENT OF STAPLES AND TISSUE TRANSECTION, AND PREVENT PATIENT HARM. 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 LAPAROSCOPIC SIGMOIDECTOMY. WHILE FIRING FOR THE FUNCTIONAL END-TO-END RE-CONSTRUCTION FOR THE SECOND TIME, THE DEVICE WOULD NOT FIRE. THE SURGEON COULD CLAMP THE TISSUE AND PRESS THE GREEN FIRING BUTTON BUT COULD NOT FIRE THE DEVICE. THE CASE WAS COMPLETED USING A NEW HANDLE AND NEW RELOAD. OOZING AND BLEEDING OCCURRED AS A RESULT BUT THERE WAS NO TISSUE DAMAGE OR ADDITIONAL INTERVENTION REQUIRED. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827605 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN NORTH HAVEN-MFG EGIA60AMT N7D0690KX 30884523003219

    Patients

    Seq Age Sex Outcome Treatment
    1