BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPS® HANDPIECE - MAGNUM® II

    MDR report key: 5625566 · Received May 3, 2016

    Report

    Report Number
    1045254-2016-00128
    Event Type
    Injury
    Date Received
    May 3, 2016
    Date of Event
    April 7, 2016
    Report Date
    April 7, 2016
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ERL
    PMA / PMN Number
    K002224
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICE: 1897102: CONSOLE 1897102 XPS 3000 2 PUMP, S/N (B)(4), LOT 32401900 MANUFACTURED 2/4/2004. PRODUCT EVALUATION: ANALYSIS RESULTS NOT AVAILABLE; DEVICES NOT RETURNED FOR EVALUATION. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    DATE OF THIS REPORT: (B)(6) 2016, DEVICE AVAILABLE FOR EVALUATION? YES. RETURN DATE: 05/09/2016. DATE MANUFACTURER RECEIVED: 05/20/2016. PRODUCT EVALUATION: * COMPLAINT DEVICE: SERVICE AND REPAIR RECEIVED DEVICE (1897200 MAGNUM II) AND WERE UNABLE TO DUPLICATE CUSTOMER¿S COMPLAINT OF OVERHEATING. PRE-REPAIR TEMPERATURE TESTS WERE PERFORMED. AFTER RUNNING THE DEVICE FOR 1 MINUTE THE TEMPERATURES MEASURED AT REFERENCE POINT #1: 87 DEGREES F, #2: 90 DEGREES F, #3 90 DEGREES F. THE DEVICE HAD A SMALL CUT ON THE CABLE. THE MOTOR/ CABLE HAVE BEEN REPLACED. THE MAGNUM II HAS BEEN SUCCESSFULLY TESTED ACCORDING TO SPECIFICATIONS. * CONCOMITANT DEVICE: SERVICE AND REPAIR FOUND THAT THE NUT OF THE CONSOLE (CONSOLE 1897102 XPS 3000) CONNECTOR IS LOOSE, THE CLAMP IS NOT MOUNTED ON THE XPS3000 (CAME ALONG AS A LOOSE PART WITH THE XPS3000), THE XPS3000 DOES NOT REACH MAXIMUM SPEED, MAGNUM II WAS 11500RPM INSTEAD OF 12000RPM AND HIGH SPEED DRILL WAS 75000RPM INSTEAD OF 80000RPM, AND THE COOLING PUMP HEAD IS CRACKED. AFTER COOLING DOWN THE DEVICE AND MAKING AN ADJUSTMENT TO THE MOTOR CONTROLLER BOARD THE SPEED IS AT DEFAULT SETTING (80000RPM). THE DEVICE WAS REPAIRED AND SUCCESSFULLY TESTED TO SPECIFICATIONS. ** SERVICE AND REPAIR TESTED THE XPS3000 AND THE MAGNUM II TOGETHER, AND FOUND NO ISSUES. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 'PATIENT GOT BURNT ON THE HAND DURING OPERATION." ADDITIONAL INFORMATION STATES THAT THE BURN IS "ON PATIENT'S RIGHT HAND BELOW IV CANNULA." "PATIENT WAS MONITORED IN RECOVERY POST-OP AS PER PROCEDURE. INJURY SEEN BY BURN UNIT DOCTORS AND THE INJURY WAS CLEANED AND DUODERM DRESSING APPLIED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282308 XPS® HANDPIECE - MAGNUM® II DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED INC. 1897200 32675700

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention