BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® HANDPIECE - VISAO®

    MDR report key: 4840312 · Received June 12, 2015

    Report

    Report Number
    1045254-2015-00199
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Report Date
    March 16, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ERL
    PMA / PMN Number
    K011321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS REPORT ARE THE RESULT OF INFORMATION NOT BEING PROVIDED BY INITIAL REPORTER. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). PRODUCT EVALUATION: SERVICE AND REPAIR FOUND THAT THERE WAS A BUR STUCK IN THE NOSE CONE. THE BEARINGS OF THE NOSE ARE BROKEN AND THERE IS CORROSION OF INTERNAL PARTS. THE VISAO WAS DISASSEMBLED AND CLEANED; O-RINGS, BEARINGS, NOSE HOUSING AND NOSE SPACER HAVE BEEN REPLACED. THE DEVICE WAS SUCCESSFULLY TESTED TO SPECIFICATIONS. PRE-REPAIR TEMPERATURE TESTING WAS NOT PERFORMED; THE DEVICE WAS NOT RUNNING WHEN IT ARRIVED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE HANDPIECE ¿STOPPED WORKING DURING USE¿. ADDITIONAL INFORMATION RECEIVED STATES ¿THAT THE DRILL HAD OVER HEATED THEN STOPPED WORKING.¿ A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386011 XPS® HANDPIECE - VISAO® DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED INC. 3334800 62408900

    Patients

    Seq Age Sex Outcome Treatment
    1