BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO¿ DRILL

    MDR report key: 4494472 · Received February 9, 2015

    Report

    Report Number
    1045254-2015-00034
    Event Type
    Malfunction
    Date Received
    February 9, 2015
    Date of Event
    January 15, 2015
    Report Date
    January 15, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF THIS REPORT: JANUARY 15, 2015. DEVICE AVAILABLE FOR EVALUATION: YES. RETURN DATE: FEBRUARY 25, 2015. PRODUCT EVALUATION: RECEIVED IPC CONSOLE ((B)(4)) FOR EVALUATION BY THE ENGINEERING GROUP. THE CONDITION OF THE DEVICE SHOWED NO SIGNIFICANT PHYSICAL DAMAGES. A HANDPIECE (BOTH PORTS) AND FOOTSWITCH (PROVIDED BY SERVICE AND REPAIR) WERE CONNECTED TO THE CONSOLE AND OPERATED AT DEFAULT SPEED. THE HANDPIECE FUNCTIONED NORMALLY. DEVICE RELEASED TO SERVICE AND REPAIR FOR INSPECTION. SERVICE AND REPAIR COULD NOT VERIFY CUSTOMER'S ISSUE; HOWEVER, THE UNIT CAME IN WITH OLD SOFTWARE. ITEM SOFTWARE WAS UPGRADED TO CURRENT SPECIFICATIONS. ITEM WAS PLACED INTO BURN IN FOR 24 HOURS EVALUATION. THE UNIT WAS TESTED AND PASSED MANUFACTURING SPECIFICATIONS. THE DRILL ((B)(4)) AND THE FOOT PEDAL WERE NOT RETURNED FOR EVALUATION. (B)(4): METHOD: ACTUAL DEVICE EVALUATED; TEMPERATURE TESTING; DEVICE-TO-DEVICE INTERACTION TESTING; LABELING EVALUATION; VISUAL INSPECTION. RESULTS: NO FAILURE DETECTED. CONCLUSION: NO FAILURE DETECTED, DEVICE OPERATED WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(4): CONCOMITANT DEVICES: 1898001: CONSOLE 1898001 IPC, S/N (B)(4), LOT 207156682 MANUFACTURED: JULY 3, 2013, 510K: K081277, ERL FOOT PEDAL: PRODUCT NUMBER AND S/N UNKNOWN. (B)(4): PRODUCT EVALUATION: NO ANALYSIS RESULTS AVAILABLE; DEVICES NOT RETURNED FOR EVALUATION. METHOD: NO TESTING METHODS PERFORMED. (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 DURING AN EAR CASE WHEN THE DOCTOR WENT TO USE THE INDIGO DRILL IT STARTED RUNNING ON ITS OWN.¿ ¿THERE WAS NO PATIENT IMPACT BUT THERE WAS A DELAY IN THE CASE OF 25 MINUTES.¿ IT HAS BEEN CONFIRMED THAT THE DRILL ¿STARTED RUNNING ON ITS OWN WHILE ON THE BACK TABLE WITHOUT BEING TOUCHED; WITHOUT THE FOOT PEDAL BEING PRESSED¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90827 INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC XOMED INC. 1845000 207207235

    Patients

    Seq Age Sex Outcome Treatment
    1