BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NO BLADE 12MM STD FIX

    MDR report key: 6208972 · Received December 28, 2016

    Report

    Report Number
    9612501-2016-01107
    Event Type
    Malfunction
    Date Received
    December 28, 2016
    Report Date
    December 2, 2016
    Manufacturer
    COVIDIEN
    Product Code
    GCJ
    PMA / PMN Number
    K151548
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HAS NOT BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SENT IF DEVICE IS RECEIVED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A SLEEVE GASTRECTOMY, WHEN THE INSTRUMENT WAS INTRODUCED THROUGH THE TROCAR, IT TORE THE SEAL. THE CURRENT PATIENT STATUS IS OK. THE LOT AND UDI NUMBERS OF THE DEVICE ARE UNAVAILABLE. THERE ARE NO PHOTOS OF THE DEVICE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859576 NO BLADE 12MM STD FIX LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ COVIDIEN NONB12STF

    Patients

    Seq Age Sex Outcome Treatment
    1