BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® HANDPIECE - VISAO®

    MDR report key: 5709548 · Received June 9, 2016

    Report

    Report Number
    1045254-2016-00182
    Event Type
    Malfunction
    Date Received
    June 9, 2016
    Date of Event
    April 27, 2016
    Report Date
    May 16, 2016
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ERL
    PMA / PMN Number
    K041523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 3334625 ¿ VISAO BUR GUARD W/O IRRIGATION; LOT NUMBER ¿ NOT PROVIDED; PRO CODE ¿ ERL; 510K - K983224. THE 3334800T (HANDPIECE): THE PRODUCT ANALYSIS HAS NOT BEEN COMPLETED FOR THE HANDPIECE. HOWEVER, THE ONE-MINUTE PRE-REPAIR TEMPERATURE TEST RESULTS COMPLETED AT INITIAL INSPECTION OF THE HANDPIECE ARE AS FOLLOWS: 115.3 DEGREES F AT THE REAR, 125.2 DEGREES F AT THE MIDDLE, AND 136.8 DEGREES F AT THE NOSE. IT WAS ALSO NOTED THAT THE NOSE BEARINGS WERE COAL-BLACK, THE INSIDE OF THE HANDPIECE WAS FILTHY AND THE MOTOR CABLE DID NOT PASS ELECTRICAL TESTING. 3334625 (BUR GUARD): THE PRODUCT ANALYSIS HAS NOT BEEN COMPLETED FOR THE BUR GUARD. HOWEVER, THE ONE-MINUTE PRE-REPAIR TEMPERATURE TEST RESULTS COMPLETED AT INITIAL INSPECTION OF THE BUR GUARD INDICATE THAT TEMPERATURE REACHED 142.2 DEGREES F.

    Additional Manufacturer Narrative · 1

    DATE MANUFACTURER RECEIVED: AUGUST 16, 2016. A 3334800T (HANDPIECE): THE PRODUCT ANALYSIS INDICATES THAT THE REPORTED COMPLAINT WAS DUPLICATED. WEAR AND TEAR WAS CONFIRMED ON THE COLLAR, RELEASE COLLAR, O-RING, BALL, NOSE, BEARING, AND OTHER COMPONENTS DUE TO STAIN AND RUST. THE DEVICE WAS DISASSEMBLED AND CLEANED. EXPENDABLE PARTS, INCLUDING BEARINGS, WERE REPLACED. THE DEVICE WAS TESTED AND PASSED TO SPECIFICATIONS. A 3334625 (BUR GUARD): IT WAS NOTED THAT THE BUR GUARD COULD NOT BE REPAIRED. THE DEVICE WAS RETURNED TO THE CUSTOMER AS A NON-REPAIRABLE DEVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE AND BUR GUARD GOT HOT. FOLLOW-UP INFORMATION INDICATES THAT THE HANDPIECE TOOK LONGER THAN ONE MINUTE TO OVERHEAT. HOWEVER, INITIAL INSPECTION OF THE HANDPIECE AND BUR CONFIRM OVERHEATING. THERE WAS NO INJURY REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370144 XPS® HANDPIECE - VISAO® DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED INC. 3334800T 73675700

    Patients

    Seq Age Sex Outcome Treatment
    1