BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRODEBRIDER 1898200T IGS M4

    MDR report key: 3813776 · Received May 15, 2014

    Report

    Report Number
    1045254-2014-00113
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ERL
    PMA / PMN Number
    K041413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED INFORMATION ON JUNE 2, 2014. PRODUCT EVALUATION: RECEIVED XPS3000 CONSOLE (1897102, CONCOMITANT DEVICE) FOR EVALUATION BY THE ENGINEERING GROUP. THE CONDITION OF THE DEVICE SHOWED NO SIGNIFICANT PHYSICAL DAMAGES. THE M4 HANDPIECE WAS NOT RECEIVED. UTILIZED A TEST M2 HANDPIECE FOR TESTING (PROVIDED BY SERVICE AND REPAIR). THE M2 HANDPIECE WAS CONNECTED TO THE XPS3000 CONSOLE AND THE CONSOLE WAS LEFT IN THE POWERED-UP STATE. AFTER ABOUT 20 MINUTES, THE IRRIGATION PUMPS STARTED TO ROTATE ON THEIR OWN WITHOUT FOOT SWITCH ACTIVATION. THE UNDERLYING CAUSE CANNOT BE DETERMINED BASED SOLELY ON THE EVALUATION RESULTS. THE UNIT WAS RELEASED TO SERVICE AND REPAIR FOR PROCESSING. SERVICE AND REPAIR EXAMINED UNIT. UNIT WAS NOT WORKING PROPERLY DUE TO MOTOR CONTROL BOARD AND DISPLAY BOARD FAILURES. THE ITEMS WERE REPLACED AND THE UNIT PLACED INTO BURN-IN FOR 24 HOURS. THE ITEM WAS TESTED AND PASSED ALL MANUFACTURING SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT MEDICAL PRODUCTS: 1897102: CONSOLE 1897102 XPS 3000 2 PUMP, S/N (B)(4), LOT 62913700, 510K: K002224, ERL MANUFACTURED: JULY 17, 2009 RECEIVED FOR EVALUATION: (B)(6) 2014. (B)(4). PRODUCT EVALUATION: HANDPIECE HAS BEEN REQUESTED, BUT FACILITY REPORTS THAT IT WILL NOT BE RETURNED FOR ANALYSIS. CONSOLE HAS BEEN RECEIVED AND IS BEING EVALUATED. SUPPLEMENTAL WILL BE FILED ONCE RESULTS ARE AVAILABLE. METHOD: NO TESTING METHODS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ¿THE SITE DID NOT STEP ON THE FOOT SWITCH/PEDAL. BUT A DRILL ATTACHED TO THE PRODUCT (CONSOLE) STARTED TO ROTATE SPONTANEOUSLY BY ITSELF.¿ THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291078 MICRODEBRIDER 1898200T IGS M4 DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED INC. 1898200T NI

    Patients

    Seq Age Sex Outcome Treatment
    1