BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART CAPNODION 02 LONG

    MDR report key: 1595215 · Received February 1, 2010

    Report

    Report Number
    MW5014627
    Event Type
    Malfunction
    Date Received
    February 1, 2010
    Date of Event
    November 16, 2009
    Report Date
    February 1, 2010
    Manufacturer
    ORIDION MEDICAL
    Product Code
    JXL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SMART CAPNO FOUND TO BREAK APART. ON MULTIPLE OCCASION (AT LEAST THREE), PHYSICIANS OBSERVED THE THIN RING WITH PLASTIC CLEAR FLAP GET DISLODGED FROM THE BITEBLOCK WHILE INSERTING THE ENDOSCOPE FOR AN UPPER ENDOSCOPY. NO HARM WAS DONE TO ANY PATIENT AND ALL BITEBLOCKS WERE REMOVED FROM THE PROCEDURE ROOMS. THE COMPANY WAS NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART CAPNODION 02 LONG BITEBLOCK JXL ORIDION MEDICAL 010128 M718769
    2 SMART CAPNIODION 02 LONG BITEBLOCK JXL ORIDION MEDICAL M692009

    Patients

    Seq Age Sex Outcome Treatment
    1