BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSION ANASTOMOSIS RING (CAR 27)

    MDR report key: 1656189 · Received March 31, 2010

    Report

    Report Number
    3005278776-2010-00037
    Event Type
    Malfunction
    Date Received
    March 31, 2010
    Date of Event
    August 4, 2008
    Report Date
    August 10, 2008
    Manufacturer
    NITI MEDICAL TECHNOLOGIES LTD.
    Product Code
    FZP
    PMA / PMN Number
    K062008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON BEHALF OF THE MFR (NITI SURGICAL SOLUTIONS LTD; 3005278776) AND THE IMPORTER (B)(4), AS NITI SURGICAL SOLUTIONS LTD SERVES AS THE DESIGNATED COMPLAINT HANDLING UNIT FOR BOTH FACILITIES. NITI HAS RE-EVALUATED THIS EVENT DURING A RETROSPECTIVE REVIEW; AND HAS DETERMINED THE EVENT TO BE MDR REPORTABLE. THE PRODUCTION HISTORY FILES INDICATED THAT THE DEVICE WAS RELEASED ACCORDING TO THE PRODUCT SPECS. THE DEVICE WAS RETURNED AND EVALUATED. NO FAILURE WAS DETECTED AND THE DEVICE WAS FOUND TO BE WITHIN ITS SPECS. THE EVENT WAS MOST PROBABLY RELATED TO USER MISTAKE.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, THE CAR DEVICE WAS LOADED BY A NURSE, AND PLACED ON THE STAND. WHEN THE DEVICE WAS PICKED UP TO USE, THE PHYSICIAN NOTICED THAT THE RING WAS IN THE PROCESS OF FALLING FROM THE DEVICE. ANOTHER DEVICE WAS OPENED AND USED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPRESSION ANASTOMOSIS RING (CAR 27) IMPLANTABLE CLIP (FZP) FZP NITI MEDICAL TECHNOLOGIES LTD. CAR 27 4327115

    Patients

    Seq Age Sex Outcome Treatment
    1