BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® HANDPIECE - VISAO®

    MDR report key: 5355050 · Received January 8, 2016

    Report

    Report Number
    1045254-2016-00011
    Event Type
    Malfunction
    Date Received
    January 8, 2016
    Report Date
    December 15, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ERL
    PMA / PMN Number
    K011321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: (1) VISAO BUR GUARD W/IRRIGATION (3334635); LOT: 73579300; MANUFACTURED: JUNE 6, 2011; 510K: K983224 (2) VISAO IRRIGATION SLEEVE (3334610); LOT: 0205390792; MANUFACTURED: SEPTEMBER 2, 2011; 510K: K983224 (3) VISAO BUR GUARD W/O IRRIGATION (3334625); LOT: 49062500; MANUFACTURED: FEBRUARY 29, 2012; 510K: K983224. (B)(4). IN RESPONSE TO MEDTRONIC¿S REQUEST FOR DEVICE RETURN, THE DEVICES WERE RETURNED AND EVALUATION IS CURRENTLY IN PROGRESS BUT NOT YET COMPLETE. HOWEVER, PRE-REPAIR TEMPERATURE TESTS WERE PERFORMED (DETAILED AS FOLLOWS): PRE-REPAIR TEMPERATURE TESTS FOUND THE FOLLOWING WITHIN A TIMEFRAME OF 30 SECONDS: REAR: 66.1 DEGREES C - MIDDLE: 60.9 DEGREES C - NOSE: 26.3 DEGREES C. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Additional Manufacturer Narrative · 1

    THE PRODUCT ANALYSIS WAS PROVIDED ON APRIL 21, 2016. THE PRODUCT ANALYSIS INDICATES THAT THE REPORTED OVERHEATING ISSUE WAS CONFIRMED UP ON RECEIVING IN SECTION. WORN BEARINGS WERE FOUND AND REPLACED ALONG WITH MULTIPLE OTHER PARTS SUCH AS THE NOSE SPACER, O-RING, MOTOR/CABLE ASSEMBLY, NOSE, MIDDLE HOUSING, WAVE WASHER, SHAFT SPACER AND BUR LOCK COVER. THE HANDPIECE WAS CLEANED, TESTED, AND PASSED TO SPECIFICATIONS. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ¿HEAT¿ WAS EXPERIENCED INTRAOPERATIVELY WHILE USING A VISAO HANDPIECE DRILL AND ITS ATTACHMENTS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER DEVICE. THIS IS THE ONLY INFORMATION PROVIDED AND THERE WAS ALSO NO REPORT OF PATIENT IMPACT OR INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13855 XPS® HANDPIECE - VISAO® DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED INC. 3334800 59855500

    Patients

    Seq Age Sex Outcome Treatment
    1