BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE ATTACHMENT - INDIGO¿ DRILL

    MDR report key: 6038980 · Received October 19, 2016

    Report

    Report Number
    1625507-2016-00041
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Report Date
    September 19, 2016
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBE
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IN RESPONSE TO MEDTRONIC¿S REQUEST FOR DEVICE RETURN, THE DEVICE WAS RETURNED AND EVALUATION IS CURRENTLY IN PROGRESS BUT NOT YET COMPLETE. HOWEVER, THE INITIAL INSPECTION IS DETAILED AS FOLLOWS: THE TEMPERATURE COMPLAINT CANNOT BE REPRODUCED. THE DISTAL BEARING IS BROKEN AND A BUR CANNOT BE INSERTED. 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

    THE FOLLOWING INFORMATION WAS RECEIVED ON NOVEMBER 14, 2016¿ ATTACHMENT 1845020, SERIAL NUMBER (B)(4) WAS USED IN THE SAME EVENT AS ATTACHMENT 1845020, SERIAL NUMBER (B)(4). BOTH DEVICES WERE SENT IN FOR EVALUATION DUE TO THE CUSTOMER NOT BEING SURE WHICH WAS CAUSING THE HEAT. CONCOMITANT PRODUCT: INDIGO OTOLOGIC ANGLED ATTACHMENT (1845020); SN: (B)(4); LOT: 209643774; DATE OF MANUFACTURE: JUNE 1, 2015; 510K: K081475. IN RESPONSE TO MEDTRONIC¿S REQUEST FOR DEVICE RETURN, BOTH DEVICES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION AND REPAIR (DETAILED AS FOLLOWS): 1845020 (P04161577/ 207768190) ¿ ANALYSIS FOUND THE DISTAL BEARING BROKEN. THE DEVICE WAS REPAIRED, TESTED AND PASSED ALL MANUFACTURING SPECIFICATIONS. 1845020 (P06118697/209643774) ¿ PRE-REPAIR TEMPERATURE TESTS REVEALED THE FOLLOWING IN A TIMEFRAME OF 1 MINUTE: 84 DEGREES FAHRENHEIT, WHICH IS WITHIN SPECIFICATION. ANALYSIS FOUND THE DISTAL BEARING BROKEN. THE DEVICE WAS REPAIRED, TESTED AND PASSED ALL MANUFACTURING SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INDIGO OTOLOGIC ANGLED ATTACHMENT ¿HEATS UP¿. THIS IS THE ONLY INFORMATION PROVIDED AND THERE WAS ALSO NO REPORT OF PATIENT IMPACT OR INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692947 IPC® HANDPIECE ATTACHMENT - INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MDT POWERED SURGICAL SOLUTIONS 1845020 0207768190

    Patients

    Seq Age Sex Outcome Treatment
    1