BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO OSCILLATING SAW

    MDR report key: 1902585 · Received November 12, 2010

    Report

    Report Number
    1811755-2010-01676
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    July 21, 2010
    Report Date
    August 21, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE HAS NOT YET BEEN RECEIVED AT THE MANUFACTURER FOR TESTING. THE CUSTOMER INDICATED THEY WERE NOT INTERESTED IN PARTICIPATING IN ANY INVESTIGATION REGARDING THIS INCIDENT, HOWEVER, THE PRODUCT RETURN WAS STILL REQUESTED. IF THE PRODUCT IS RETURNED, AN EVALUATION WILL BE CONDUCTED AND A FOLLOW-UP REPORT WOULD BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SURGEON CONTACTED A PATIENT'S HEART WITH THE SAW BLADE OF THIS HANDPIECE DURING A SURGICAL PROCEDURE. IT IS UNKNOWN AT THIS TIME IF THERE WAS ANY INJURY TO THE PATIENT AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO OSCILLATING SAW SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTAC HBE STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK