BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVIDIEN

    MDR report key: 4184239 · Received October 7, 2014

    Report

    Report Number
    4184239
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 7, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ENDOSTITCH NEEDLE ES-9 OF A 2-0 POLYSORB SUTURE BROKE IN HALF WHILE BEING USED IN PATIENT ON AN ENDOSTITCH SUTURING DEVICE. HALF REMAINED IN SUTURING DEVICE, HALF IN PATIENT AND UNABLE TO SEE. AN X-RAY WAS PERFORMED. ONE OF THE NEEDLES FROM THE ENDOSTITCH BROKE OFF WITHIN THE WALL OF THE STOMACH NEAR THE STAPLE LINE OF GASTRIC POUCH. SURGEON WAS NOT ABLE TO RETRIEVE IT. AN X-RAY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626414 COVIDIEN CLIP, IMPLANTABLE GAM COVIDIEN * B3L0484X

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR