BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE ATTACHMENT - INDIGO¿ DRILL

    MDR report key: 6322773 · Received February 10, 2017

    Report

    Report Number
    1625507-2017-00008
    Event Type
    Malfunction
    Date Received
    February 10, 2017
    Date of Event
    January 17, 2017
    Report Date
    January 17, 2017
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    HBE
    UDI-DI
    00643169296008
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 1845000: INDIGO HIGH SPEED OTOLOGIC DRILL, SERIAL # (B)(4), LOT # 209108597, MANUFACTURE DATE: JAN/12/2015, 510(K) #K081475,UDI # (B)(4); 1845010: INDIGO OTOLOGIC STRAIGHT ATTACHMENT, SERIAL # (B)(4), LOT # 209315088, MANUFACTURE DATE: MAR/12/2015, 510(K) # K081475, UDI # (B)(4). THE INDIGO ANGLED ATTACHMENT (PRODUCT # 1845020) WAS RETURNED FOR ANALYSIS. PRE-REPAIR TEMPERATURE TESTING COULD NOT BE PERFORMED ON THE DEVICE SINCE THE ATTACHMENT COULD NOT BE LOCKED WITH THE HANDPIECE. DEVICE EVALUATION NOT COMPLETE AT THIS TIME. COMPLETION OF DEVICE EVALUATION ANTICIPATED. THE INDIGO DRILL (PRODUCT # 1845000) WAS RETURNED FOR ANALYSIS. PRE-REPAIR TEMPERATURE TESTING WAS PERFORMED ON THE DEVICE. PRE-REPAIR TEMPERATURE TESTING COULD NOT CONFIRM THE REPORTED EVENT OF OVERHEATING. PRE-REPAIR TEMPERATURES AFTER RUNNING THE DEVICE FOR 1 MINUTE WERE THE FOLLOWING: T1¿ 26.5 DEGREES C AND T2 ¿ 25.9 DEGREES C. PRE-REPAIR INSPECTION ALSO INDICATED THAT THE DRILL WAS NOISY. DEVICE EVALUATION NOT COMPLETE AT THIS TIME. COMPLETION OF DEVICE EVALUATION ANTICIPATED. THE INDIGO STRAIGHT ATTACHMENT (PRODUCT # 1845010) WAS RETURNED FOR ANALYSIS. PRE-REPAIR TEMPERATURE TESTING WAS PERFORMED ON THE DEVICE. PRE-REPAIR TEMPERATURE TESTING COULD NOT CONFIRM THE REPORTED EVENT OF OVERHEATING. PRE-REPAIR TEMPERATURE AFTER RUNNING THE DEVICE FOR 1 MINUTE WAS 27.4 DEGREES C. PRE-REPAIR INSPECTION INDICATED THAT THE DEVICE IS WORKING WELL. DEVICE EVALUATION NOT COMPLETE AT THIS TIME. COMPLETION OF DEVICE EVALUATION ANTICIPATED.

    Additional Manufacturer Narrative · 1

    MODEL # 1845000 (INDIGO DRILL): THE PRODUCT ANALYSIS INDICATES THAT THE OVERHEATING COULD NOT BE REPLICATED. HOWEVER, ABNORMAL NOISE WAS CONFIRMED AND OCCURRED AT START-UP. SOME PARTS, INCLUDING THE BEARINGS, WERE REPLACED. THE DEVICE WAS CLEANED AND SUCCESSFULLY TESTED TO SPECIFICATION. MODEL # 1845010 (INDIGO STRAIGHT ATTACHMENT): THE PRODUCT ANALYSIS INDICATES THAT THERE WAS NO MALFUNCTION. SOME PARTS, INCLUDING THE BEARINGS, WERE REPLACED. THE DEVICE WAS CLEANED AND SUCCESSFULLY TESTED TO SPECIFICATION. MODEL # 1845020 (INDIGO ANGLED ATTACHMENT): THE PRODUCT ANALYSIS INDICATES THAT THE BUR COULD NOT BE LOCKED INTO THE HANDPIECE. SOME PARTS, INCLUDING THE BEARINGS, WERE REPLACED. THE DEVICE WAS CLEANED AND SUCCESSFULLY TESTED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INDIGO HIGH SPEED DRILL AND ATTACHMENTS OVERHEATED SOMETIMES DURING THE PROCEDURE. THE PHYSICIAN CONTINUED THE PROCEDURE WITH THE SAME HANDPIECE. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106101 IPC® HANDPIECE ATTACHMENT - INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC XOMED, INC. 1845020 209213915 00643169296008

    Patients

    Seq Age Sex Outcome Treatment
    1