BEUDAMED
    FDA Adverse Event Other Summary report: N

    12FR X1.5CM ENTRISTAR SLG X1

    MDR report key: 2931386 · Received January 22, 2013

    Report

    Report Number
    9612030-2013-00001
    Event Type
    Other
    Date Received
    January 22, 2013
    Date of Event
    December 26, 2012
    Report Date
    January 8, 2013
    Manufacturer
    COVIDIEN
    Product Code
    KNT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE (B)(4) 2013. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH AN ENTRISTAR. THE CUSTOMER STATED THE ENTRISTAR TERMINAL PART DETACHED AND REMAINED IN THE PT'S INTESTINE. THE MEDICAL FACILITY TRIED TO REMOVE THE BROKEN PIECE BY ENDOSCOPIC PROCEDURE, WITH NO SUCCESS. AN ADD'L PROCEDURE WILL BE ATTEMPTED IF THE PTS' HEALTH PERMITS. NO FURTHER INFO IS KNOWN ON THE HEALTH OF THE PT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30982 12FR X1.5CM ENTRISTAR SLG X1 ENTRISTAR KNT COVIDIEN 8884741215 A1104747

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other