BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM PEEK MULTIFUNCTION HANDLE

    MDR report key: 2961986 · Received January 22, 2013

    Report

    Report Number
    2936485-2013-90035
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    KOG
    PMA / PMN Number
    K973259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 UNIT WAS RECEIVED BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29824 5MM PEEK MULTIFUNCTION HANDLE KOG STRYKER ENDOSCOPY SAN JOSE 1240627D

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK