BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO¿

    MDR report key: 4124971 · Received September 29, 2014

    Report

    Report Number
    1045254-2014-00235
    Event Type
    Malfunction
    Date Received
    September 29, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT PRODUCT: 1845020, ATTACHMENT 1845020, INDIGO OTOL ANGLED, S/N (B)(4), LOT 207812383. MANUFACTURED AT MEDTRONIC XOMED, INC., ON 1-7-2014. 510K: K081475, HBE (B)(4). PRODUCT EVALUATION: NO EVALUATION RESULTS AVAILABLE; DEVICE NOT RETURNED FOR ANALYSIS. METHOD: NO TESTING METHODS PERFORMED.(B)(4).

    Additional Manufacturer Narrative · 1

    NOTE: THE INITIAL MDR WAS SUBMITTED FOR 1845000, INDIGO HIGH SPEED OTOLOGIC DRILL, S/N (B)(4). THE DRILL WAS NOT RETURNED FOR EVALUATION, THERE ARE NO ANALYSIS RESULTS AVAILABLE FOR THIS DEVICE. THIS MDR IS BEING SUBMITTED TO PROVIDE THE ANALYSIS RESULTS FOR THE CONCOMITANT DEVICE ON THE INITIAL REPORT, 1845020, INDIGO ANGLED ATTACHMENT, S/N (B)(4), LOT 207812383. RETURNED TO MANUFACTURER: OCTOBER 6, 2014. DATE RECEIVED BY MANUFACTURER: OCTOBER 27, 2014. PRODUCT EVALUATION: ONE INDIGO ATTACHMENT WAS RECEIVED FOR EVALUATION, CONCOMITANT DEVICE 1845020; THE INDIGO HANDPIECE WAS NOT RETURNED FOR EVALUATION. THE RETURNED ATTACHMENT COULD NOT BE LOCKED OR UNLOCKED INTO ANOTHER INDIGO HANDPIECE. MULTIPLE FACTORS SUCH AS WORN BEARINGS OR INTERNAL CORROSION MAY HAVE PREVENTED THE ATTACHMENT TO LOCK TO INTO THE HANDPIECE ASSEMBLY. IF THE ATTACHMENT DOES NOT LOCK PROPERLY AND THE HANDPIECE IS OPERATED, IT CAN LEAD TO POSSIBLE OVERHEATING OF HANDPIECE DURING USE. THE INSTRUCTIONS FOR USE PROVIDES ADEQUATE WARNING AROUND DEVICE OVERHEATING: - SMOKE AND/OR EXCESSIVE HEAT MAY BE GENERATED IF ATTACHMENT IS NOT IN THE FULLY LOCKED POSITION. THIS MAY RESULT IN THERMAL INJURY TO THE SURGEON OR STAFF. (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 OTOLOGY SURGERY ¿THE ANGLED ATTACHMENT IS GETTING HEATED UP AND IS UNABLE TO USE IT FOR SURGERY.¿ IT WAS STATED THAT THE DEVICE WAS HEATING UP IN LESS THAN 1 MINUTE; AFTER WHICH IT BECAME TOO HOT TO HOLD. ANOTHER DRILL WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605835 INDIGO¿ DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC XOMED INC. 1845000 207713388

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR