BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYS 6 RECIP

    MDR report key: 2082094 · Received April 26, 2011

    Report

    Report Number
    1811755-2011-01416
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S EVALUATION STATES THAT THE STICKY TRIGGER WAS DUE TO A TOGGLE AND SLIDE SWITCH THAT NEEDED UPGRADED. THE DEVICE WAS REPAIRED AND RETURNED TO THE ACCOUNT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE'S TRIGGER WAS STICKY. THIS WAS DISCOVERED WHEN THE DEVICE WAS AT THE MANUFACTURER FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYS 6 RECIP KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK