BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYS 6 RECIP

    MDR report key: 2241637 · Received September 2, 2011

    Report

    Report Number
    1811755-2011-03219
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 12, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR SERVICE AND EVALUATION. DURING THE INVESTIGATION, AN UNKNOWN STICKY SUBSTANCE CAME OUT OF THE DEVICE. A SAMPLE WAS TAKEN FROM THE BLADE MOUNT ASSEMBLY. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE HANDPIECE WAS RETURNED TO THE MANUFACTURER FOR SERVICE, AND DURING THE INVESTIGATION AN UNKNOWN STICKY SUBSTANCE CAME OUT OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT. THIS DID NOT OCCUR DURING A SURGICAL PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF 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