BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORACOPORT 11.5MM TROCAR

    MDR report key: 3100041 · Received April 29, 2013

    Report

    Report Number
    2647580-2013-00225
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 28, 2013
    Report Date
    April 2, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GCJ
    PMA / PMN Number
    K992288
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE RPTR: BEFORE THE PRODUCT WAS APPLIED TO THE PT, THE MEDICAL STAFF FOUND OUT THAT ON THE SURFACE OF THE SLEEVE SHOWED THE PAINT HAD PEELED OFF. THE STAFF TRIED A NEW PRODUCT, BUT FOUND THE SAME PROBLEM. FINALLY, THE THIRD PRODUCT WAS IN GOOD CONDITION AND WAS TO BE USED IN THE SURGERY. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184411 THORACOPORT 11.5MM TROCAR DISPOSABLE SURGICAL DEVICE GCJ COVIDIEN, FORMERLY USSC PD20965X

    Patients

    Seq Age Sex Outcome Treatment
    1