BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE ATTACHMENT - INDIGO¿ DRILL

    MDR report key: 5960629 · Received September 19, 2016

    Report

    Report Number
    1045254-2016-00312
    Event Type
    Malfunction
    Date Received
    September 19, 2016
    Report Date
    August 25, 2016
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 1845000: HIGH SPEED INDIGO OTOLOGIC DRILL, SERIAL # (B)(4), LOT # 209455624, MANUFACTURED DATE -APR/16/2015, 510(K) # K081475. 1845010: INDIGO OTOLOGIC STRAIGHT ATTACHMENT, SERIAL # (B)(4), LOT # 207228997, MANUFACTURED DATE - JUL/29/2013, 510(K) # K081475. 1845020: INDIGO OTOLOGIC ANGLED ATTACHMENT, SERIAL # (B)(4), LOT # 208923580, MANUFACTURED DATE - NOV/26/2014, 510(K) # K081475. INDIGO OTOLOGIC ANGLED ATTACHMENT (MODEL # 1845020, SERIAL # (B)(4)) AND INDIGO OTOLOGIC STRAIGHT ATTACHMENT (MODEL # 1845010, SERIAL # (B)(4)) WERE NOT RETURNED FOR ANALYSIS. HIGH SPEED INDIGO OTOLOGIC DRILL (MODEL # 1845000, SERIAL # (B)(4)) WAS RETURNED FOR ANALYSIS. ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT OF EXCESSIVE HEAT. PRE-REPAIR TEMPERATURE TESTING WAS PERFORMED. THE AMBIENT TEMPERATURE WAS 72.4 DEGREES F. PRE-REPAIR TEMPERATURES AT 1 MIN WERE THE FOLLOWING: T1 ¿ 73.9 DEGREES F AND T2 - 76.1 DEGREES F. THERE WAS NO FAULT FOUND WITH THE DEVICE. INDIGO OTOLOGIC ANGLED ATTACHMENT (MODEL # 1845020, SERIAL # (B)(4)) WAS RETURNED FOR ANALYSIS. ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT OF EXCESSIVE HEAT. PRE-REPAIR TEMPERATURE TESTING WAS PERFORMED. PRE-REPAIR TEMPERATURE OF THE COLLET AT 1 MIN WAS 74.1 DEGREES F. 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

    DEVICE RETURNED ON 10/3/2016. DATE MFR. REC: 10/26/2016. INDIGO OTOLOGIC ANGLED ATTACHMENT (MODEL # 1845020, SERIAL # (B)(4)) WAS RETURNED FOR ANALYSIS. ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT OF EXCESSIVE HEAT. PRE-REPAIR TEMPERATURE TESTING WAS PERFORMED. PRE-REPAIR TEMPERATURE OF DEVICE AFTER RUNNING FOR 5 MINUTES WAS 78.1 DEGREES F. ANALYSIS INDICATED THAT THE BEARINGS ON THE DEVICE WERE CORRODED. THE DEVICE WAS REPAIRED, TESTED TO MANUFACTURER PRODUCT SPECIFICATIONS AND RETURNED TO THE CUSTOMER. INDIGO OTOLOGIC STRAIGHT ATTACHMENT (MODEL # 1845010, SERIAL # (B)(4)) WAS RETURNED FOR ANALYSIS. ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT OF EXCESSIVE HEAT. PRE-REPAIR TEMPERATURE TESTING WAS PERFORMED. PRE-REPAIR TEMPERATURE OF DEVICE AFTER RUNNING FOR 5 MINUTES WAS 96.2 DEGREES F. ANALYSIS INDICATED THAT THE BEARINGS ON THE DEVICE WERE CORRODED. THE DEVICE WAS REPAIRED, TESTED TO MANUFACTURER PRODUCT SPECIFICATIONS AND RETURNED TO THE CUSTOMER. INDIGO OTOLOGIC ANGLED ATTACHMENT (MODEL # 1845020, SERIAL # (B)(4)) WAS FURTHER EVALUATED. EVALUATION INDICATED THAT THE BEARINGS WERE CORRODED, THE GEARS WERE WORN AND INPUT/OUTPUT SHAFT WAS WORN. THE DEVICE WAS REPAIRED, TESTED TO MANUFACTURER PRODUCT SPECIFICATIONS AND RETURNED TO THE CUSTOMER. METHODS: ACTUAL DEVICE EVALUATED; VISUAL INSPECTION. CONCLUSION: DEVICE REPAIRED AND RETURNED; UNABLE TO CONFIRM COMPLAINT.

    Additional Manufacturer Narrative · 1

    (B)(4): INDIGO DRILL UDI # ¿ (B)(4). INDIGO STRAIGHT ATTACHMENT UDI # - (B)(4). INDIGO ANGLED ATTACHMENT UDI # - (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 THE INDIGO HANDPIECE AND ATTACHMENTS WERE OVERHEATING. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611868 IPC® HANDPIECE ATTACHMENT - INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC XOMED INC. 1845020 207271903

    Patients

    Seq Age Sex Outcome Treatment
    1