BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHEATH, 2.9MM DIAGNOSTIC INNER

    MDR report key: 2944253 · Received January 9, 2013

    Report

    Report Number
    2936485-2013-90013
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    HIH
    PMA / PMN Number
    K040390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. NOTE: THE REASON FOR THE SERIALIZATION STARTING WITH 90XXX IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER'S ELECTRONIC COMPLAINT SYSTEMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TOP OF THE UNIT BROKE APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11459 SHEATH, 2.9MM DIAGNOSTIC INNER HIH STRYKER ENDOSCOPY SAN JOSE 1255894

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK