BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO¿

    MDR report key: 4256100 · Received November 17, 2014

    Report

    Report Number
    1045254-2014-00296
    Event Type
    Malfunction
    Date Received
    November 17, 2014
    Date of Event
    October 23, 2014
    Report Date
    October 23, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS RECEIVED CONDITION: RECEIVED INDIGO MOTOR, STRAIGHT ATTACHMENT, AND ANGLED ATTACHMENT FOR EVALUATION BY THE ENGINEERING GROUP. THE CONDITION OF THE DEVICES SHOWED NO SIGNIFICANT PHYSICAL DAMAGES. OBSERVATIONS: THE INDIGO MOTOR AND ONE ATTACHMENT WERE CONNECTED TO THE IPC AND OPERATED AT DEFAULT SPEED. IT WAS CONFIRMED THAT THE MOTOR WAS DEFECTIVE. BOTH ATTACHMENTS WERE THEN RUN WITH A KNOWN GOOD MOTOR AND THEY FUNCTIONED NORMALLY. THE ATTACHMENTS WERE EVALUATED WITH THE HANDPIECE AND COULD NOT VERIFY OVERHEATING. ONE MINUTE TEMPERATURE TESTING MEASURED 85°F FOR THE STRAIGHT ATTACHMENT PART # 1845010. ONE MINUTE TEMPERATURE TESTING MEASURED 86°F FOR THE ANGLED ATTACHMENT PART # 1845020. THE ATTACHMENT EVALUATION FOUND NO FAULT WITH THE DEVICES. THE MOTOR OF THE HANDPIECE (PART # 1845000) FAILED. METHODS ¿ INTEROPERABILITY, RESULTS ¿ MECHANICAL PROBLEM. CONCLUSION ¿ DEVICE REPAIRED AND RETURNED. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4); MANUFACTURED APRIL 18, 2014; SERIAL NUMBER (B)(4); LOT NUMBER 208267659; 510K NUMBER K081475 1845020: ATTACHMENT INDIGO OTOLOGY ANGLED; MANUFACTURED MARCH 31, 2014; SERIAL NUMBER (B)(4); LOT NUMBER 208197605; 510K NUMBER K081475. (B)(4). AN INITIAL INSPECTION WAS PERFORMED UPON RETURN OF THE DEVICE TO MEDTRONIC (B)(4). THE PRE-REPAIR 1 MINUTE TEMPERATURE TEST RESULTS WERE 136.4 DEGREES F (58 DEGREES C) AND 121.6 DEGREES F (49.8 DEGREES C). THE PRODUCT ANALYSES HAVE NOT YET BEEN COMPLETED. THE DEVICES HAVE BEEN FORWARDED TO MEDTRONIC XOMED FOR ANALYSIS AND/OR REPAIR. RESULTS: RESULTS PENDING COMPLETION OF EVALUATION. (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 WHEN THE ATTACHMENTS WERE LOCKED, THEY DID NOT MAKE THE SECOND CLICKING SOUND AS THEIR LOCK MECHANISMS USUALLY DO. ALTHOUGH THE ARROW WAS TURNED TO THE LOCK POSITION AND THE BUR DID NOT COME OFF, THE HANDPIECE GENERATED HEAT WHEN USED. THE BUR ALSO DID NOT ROTATE IN LOW SPEED. SINCE THE DOCTOR WAS FAMILIAR WITH THE "HALF-LOCKED STATE," WHICH WAS OFTEN ASSOCIATED WITH HEAT GENERATION, THE DOCTOR TRIED MANY TIMES TO SOLVE THE ISSUE, BUT THE CONDITION DID NOT IMPROVE. THUS THE DEVICES ARE SUSPECTED TO BE DEFECTIVE. THIS EVENT OCCURRED DURING A TYMPANOPLASTY. THE PROCEDURE WAS CONTINUED USING A BACK-UP DEVICE WITHOUT CAUSING ANY DELAY OR ADVERSE EFFECT. THERE WAS NO INJURY REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743321 INDIGO¿ DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC XOMED INC. 1845000 208309894

    Patients

    Seq Age Sex Outcome Treatment
    1