BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM PEEK MULTIFUNCTION HANDLE

    MDR report key: 2953901 · Received January 14, 2013

    Report

    Report Number
    2936485-2013-90022
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 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 INFO 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 BY THE COMPANY REP THAT THE HANDLES ARE BREAKING AT THE FINGER REST, THE INSULATION, OR AT THE CAUTERY POST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19993 5MM PEEK MULTIFUNCTION HANDLE KOG STRYKER ENDOSCOPY SAN JOSE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK