BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA ADAPTER XL

    MDR report key: 4112861 · Received September 24, 2014

    Report

    Report Number
    1219930-2014-00852
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GAG
    PMA / PMN Number
    K121510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW UP REPORT SENT TO FDA ON 12/31/2014. BASED ON NEW INFORMATION PROVIDED BY THE ACCOUNT, THIS REPORT WAS DETERMINED NOT TO BE REPORTABLE.

    Description of Event or Problem · 1

    PROCEDURE: RECTOPEXY.ACCORDING TO THE REPORTER:THE RELOAD WOULD NOT CLOSE OR ARTICULATE. LIGHTS INDICATED ALL WHITE, ALL GREEN WITH NO BLUE LIGHTS. THE ADAPTER WAS REPLACED WITH A STANDARD ADAPTER AND WORKED PROPERLY.SURGERY TIME WAS NOT DELAYED BY MORE THAN 30 MINUTES.NO REINFORCEMENT MATERIAL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595586 ENDO GIA ADAPTER XL REUSABLE SURGICAL STAPLER GAG COVIDIEN, FORMERLY US SURGICAL A DIVISON EGIAADAPTXL N4G0408ULX

    Patients

    Seq Age Sex Outcome Treatment
    1