BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.5MM CANNULA, 2 ROTATING STOPCOCKS

    MDR report key: 3771643 · Received April 24, 2014

    Report

    Report Number
    0002936485-2014-00265
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 26, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    NBH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THEREFORE, THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED. THE POSSIBLE ROOT CAUSE FOR THE FAILURE CAN BE DUE TO: 1) IMPROPER STERILIZATION METHODS 2) HANDLING ERROR. HOWEVER, THIS CANNOT BE CONFIRMED SINCE THE UNIT WAS NOT RETURNED. IN THE EVENT THAT THE UNIT IS RETURNED, A FULL EVALUATION WILL BE CONDUCTED AND A FOLLOW UP REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SEAL/GASKET IS FALLING OUT WHEN IN USE. IT WAS FURTHER STATED THAT THE UNIT BECOMES UNSEATED, TWISTED, AND DISINTEGRATES. A REPLACEMENT UNIT WAS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SEAL/GASKET IS FALLING OUT WHEN IN USE. IT WAS FURTHER STATED THAT THE UNIT BECOMES UNSEATED, TWISTED, AND DISINTEGRATES. A REPLACEMENT UNIT WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250302 6.5MM CANNULA, 2 ROTATING STOPCOCKS ACCESSORIES,ARTHROSCOPIC NBH STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1