BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTACK* 5MM INSTRUMENT

    MDR report key: 4120821 · Received September 26, 2014

    Report

    Report Number
    2647580-2014-00809
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    January 7, 2013
    Report Date
    January 10, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    OCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: WHEN THE DOCTOR WAS FIRING THE DEVICE, THE SHAFT BROKE. NO PIECES FALL INTO THE PATIENT CAVITY. DOCTOR USED ANOTHER 174006 AND WAS ABLE TO CONTINUE THE CASE. O REINFORCEMENT MATERIAL WAS USED DURING THE CASE. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. NO DEVICE FRAGMENT OR COMPONENT FELL INTO THE PATIENT'S CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601878 PROTACK* 5MM INSTRUMENT PROTACK OCW COVIDIEN, FORMERLY USSC PUERTO RICO INC 174006 P2F0322X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other