BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA ADAPTER XL

    MDR report key: 6186232 · Received December 19, 2016

    Report

    Report Number
    1219930-2016-01371
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Report Date
    November 23, 2016
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GDW
    PMA / PMN Number
    K133762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL ATTEMPTS TO OBTAIN INFORMATION AND THE DEVICE HAVE BEEN MADE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH NEW DETAILS IF THEY BECOME AVAILABLE. EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE STAPLER ADAPTER OPENED BY THE ACCOUNT. THIS EVALUATION WAS BASED ON A TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS, ENGINEERING REVIEW OF THE PRODUCT AND AN EVALUATION OF THE RETURNED DEVICE. VISUAL INSPECTION NOTED NO ABNORMALITIES. FUNCTIONAL EVALUATION FOUND THAT THE ADAPTER HAD A BROKEN WELD ON THE ARTICULATION HOUSING THAT COUPLES THE ARTICULATION LINK WITH THE TRANSMISSION. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THESE DEVICES LOT NUMBERS WERE RELEASED MEETING ALL MEDTRONIC QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. A PRODUCT ENHANCEMENT HAS BEEN IMPLEMENTED TO PREVENT THIS CONDITION FROM RE-OCCURRING. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: WHEN USING THE DEVICE, THE SHAFT DOES NOT ALLOW THE RELOAD TO BE ROTATED/ARTICULATED. WE TRIED MULTIPLE RELOADS AND IT DID NOT WORK. WHEN USING A DIFFERENT SHAFT, THE STAPLER WAS ABLE TO ARTICULATE/ROTATE THE RELOADS. INJURY OR HARM? 14. WAS THE PROCEDURE EXTENDED BY 30 MINUTES OR MORE?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838639 ENDO GIA ADAPTER XL STAPLE, IMPLANTABLE GDW COVIDIEN, FORMERLY US SURGICAL A DIVISON EGIAADAPTXL N5K0118LX

    Patients

    Seq Age Sex Outcome Treatment
    1