BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVIDIEN

    MDR report key: 7616508 · Received June 19, 2018

    Report

    Report Number
    1047429-2018-00005
    Event Type
    Malfunction
    Date Received
    June 19, 2018
    Date of Event
    May 1, 2018
    Report Date
    June 19, 2018
    Manufacturer
    COVIDIEN
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AVID MEDICAL ISSUED FORMAL COMPLAINT # (B)(4) TO THE MANUFACTURER COVIDIEN CONCERNING THE MISFIRING OF THE SURGICLIP FOR ITEM NO. 134031, MANUFACTURER LOT# P6E0131CX.

    Description of Event or Problem · 1

    AVID MEDICAL IS THE MANUFACTURER OF A CUSTOM PROCEDURE TRAY THAT INCLUDES THE FOLLOWING COMPONENT: CLIP, SURGICLIP, VENDOR PART # 134031 MANUFACTURED BY COVIDIEN, FDA ESTABLISHMENT # (B)(4). AVID MEDICAL RECEIVED A COMPLAINT ORIGINATED BY (B)(6) MEDICAL CENTER, (B)(6) STATING THAT THE SURGICLIP WAS MISFIRING AND IS UNSAFE TO USE. THE COMPLAINED CLIP, SURGICLIP PART IS AVAILABLE FOR EVALUATION, BUT HAS NOT BEEN SENT TO THE MANUFACTURER (COVIDIEN) AS OF YET. AVID MEDICAL ISSUED FORMAL COMPLAINT # (B)(4) TO THE MANUFACTURER COVIDIEN CONCERNING THE MISFIRING OF THE SURGICLIP FOR ITEM NO. 134031, MANUFACTURER LOT# P6E0131CX. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460057 COVIDIEN CLIP, IMPLANTABLE FZP COVIDIEN 134031 P6E0131CX

    Patients

    Seq Age Sex Outcome Treatment
    1