BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUMOSURE INSUFFLATION TUBING

    MDR report key: 1183543 · Received September 24, 2008

    Report

    Report Number
    1183543
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    September 19, 2008
    Report Date
    September 24, 2008
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    FCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    TIP BROKEN OFF TUBING WHERE IT CONNECTS TO LAPAROSCOPIC TROCAR.====================== MANUFACTURER RESPONSE FOR INSUFFLATION TUBING, PNEUMOSURE INSUFFLATION TUBING======================THE REP VERBALLY REPORTED THAT THE COMPANY HAS BEEN AWARE OF THE PROBLEM WITH THE GLUE IN THIS TUBING FOR SEVERAL MONTHS. THEY ARE APPARENTLY WORKING ON A SOLUTION, BUT NO ADEQUATE REPLACEMENT WILL BECOME AVAILABLE FOR SEVERAL MORE WEEKS AND THEY CONTINUE TO PROVIDE TUBING WITH KNOWN BREAKAGE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PNEUMOSURE INSUFFLATION TUBING TUBING, INSUFFLATION FCX STRYKER ENDOSCOPY 620-040-690 0643074

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR