BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDO GIA¿ ULTRA UNIVERSAL SINGLE USE STAPLER (12MM)

    MDR report key: 6074162 · Received November 2, 2016

    Report

    Report Number
    2647580-2016-00910
    Event Type
    Death
    Date Received
    November 2, 2016
    Date of Event
    September 14, 2016
    Report Date
    October 7, 2016
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GDW
    PMA / PMN Number
    K111825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE OPENED BY THE ACCOUNT. THIS EVALUATION WAS BASED ON A MEDICAL AND TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS, AND AN EVALUATION OF THE RETURNED DEVICE. VISUAL INSPECTION OF THE INSTRUMENT FOUND NO ABNORMALITIES. FUNCTIONALLY, THE INSTRUMENT WAS LOADED WITH A RELOAD. THE INSTRUMENT AND LOADING UNIT WERE APPLIED TO TEST MEDIA. ALL STAPLES WERE PLACED AND TEST MEDIA WAS CLEANLY TRANSECTED. AN ACCESS HOLE WAS CUT INTO THE INSTRUMENT BODY FOR VISUALIZATION ON THE FIRING RACK. THE FIRING RACK WAS FOUND TO BE IN GOOD WORKING CONDITION. VISUAL AND FUNCTIONAL TESTING OF THE RETURNED PRODUCT CONFIRMED THE PRODUCT MET QUALITY RELEASE SPECIFICATIONS THAT WERE TESTED REGARDING THE REPORTED CONDITIONS. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS DEVICE LOT NUMBER WAS RELEASED MEETING ALL MEDTRONIC QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. A REVIEW OF THE CURRENT HISTORICAL COMPLAINT DATA REVEALS THAT THE COMPLAINT MODE OF INSTRUMENT BROKE WAS IDENTIFIED AS A TREND IN (B)(6) 2016. BASED ON THE PRODUCT ANALYSIS, THE FAILURE WAS NOT CONFIRMED TO BE ATTRIBUTED TO THE REPORTED EVENT. THE FILE WILL BE CLOSED AS TESTED SATISFACTORILY AS THE DEVICE WAS FOUND TO MEET ALL VISUAL AND FUNCTIONAL TEST SPECIFICATIONS. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY AMENDED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HAS BEEN RECEIVED BUT EVALUATION NOT YET BEGUN. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). USER FACILITY LISTED IN INITIAL REPORTER. (B)(4). THE SURGEON WAS CONTACTED, HOWEVER, HE DOES NOT WISH TO DISCUSS THE CASE FURTHER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER; DURING A VIDEO ASSISTED THORACOSCOPIC SURGERY, THE SURGEON HAD A DIFFICULT TIME GETTING THE STAPLER TO FIRE OR WORK AND WHEN ATTEMPTING A FIRE OF THE DEVICE, THE HANDLE MADE A NOISE AND CRACKED. THE APPLICATION SITE WAS NOT THICK TISSUE. THE PATIENT HAD AIR LEAKS DURING THE OPERATION AND POST-OPERATIVELY THAT WERE NOT ABLE TO BE FIXED. THE STAPLES REPORTEDLY NOT FORMED CORRECTLY AND THE STAPLE LINE WAS INCOMPLETE. THE PATIENT PASSED AWAY. THE SURGEON SAID THERE WERE MULTIPLE THINGS WRONG WITH THE PATIENT/CASE. ANOTHER MANUFACTURER'S REINFORCEMENT MATERIAL WAS USED IN CONJUNCTION WITH THE DEVICE AT THE TIME. IT WAS PROVIDED BY THE SURGEON THAT THE PATIENT WAS VERY SICK. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723747 ENDO GIA¿ ULTRA UNIVERSAL SINGLE USE STAPLER (12MM) STAPLE, IMPLANTABLE GDW COVIDIEN, FORMERLY USSC PUERTO RICO INC EGIAUSTND P6F0320X

    Patients

    Seq Age Sex Outcome Treatment
    1 Death