BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE - INDIGO¿ DRILL

    MDR report key: 6527344 · Received April 27, 2017

    Report

    Report Number
    1045254-2017-00125
    Event Type
    Malfunction
    Date Received
    April 27, 2017
    Report Date
    April 5, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    UDI-DI
    00613994933713
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 1845010: INDIGO OTOLOGIC STRAIGHT ATTACHMENT, SERIAL # (B)(4), LOT # 208823441, MANUFACTURE DATE: OCT/16/2014, 510(K) #K081475, (B)(4). 1845020: INDIGO OTOLOGIC ANGLED ATTACHMENT, SERIAL # (B)(4), LOT # 208792571, MANUFACTURE DATE: OCT/6/2014, 510(K) # K081475, (B)(4). THE INDIGO HANDPIECE WAS RETURNED FOR ANALYSIS. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN. THE STRAIGHT AND ANGLED ATTACHMENTS WERE NOT RETURNED FOR ANALYSIS. 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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION HAS BEEN COMPLETED FOR THE INDIGO HANDPIECE (PRODUCT # 1845000). ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT OF HEATING UP. PRE-REPAIR TEMPERATURE TESTING WAS PERFORMED. PRE-REPAIR TEMPERATURES AFTER RUNNING THE DEVICE FOR 1 MINUTE AT 60K WERE THE FOLLOWING: FRONT ¿ 78 DEGREES F AND REAR ¿ 78 DEGREES F. THE AMBIENT TEMPERATURE WAS 76 DEGREES F. EVALUATION FOUND NO FAULT WITH THE DEVICE. THE DEVICE WAS TESTED TO ALL MANUFACTURING PRODUCT SPECIFICATIONS AND RETURNED TO THE CUSTOMER. INDIGO STRAIGHT ATTACHMENT (PRODUCT # 1845010) AND INDIGO ANGLED ATTACHMENT (PRODUCT # 1845020) WERE RETURNED. HOWEVER, IT WAS CONFIRMED THAT THERE WAS ON ALLEGED COMPLAINT AGAINST BOTH THE ATTACHMENTS. THE CUSTOMER¿S COMPLAINT WAS FOR ONLY THE INDIGO HANDPIECE. THUS, NO ANALYSIS WAS PERFORMED ON THESE ATTACHMENTS. THE CUSTOMER REQUESTED THE DEVICES TO BE RETURNED UN-REPAIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HANDPIECE HEATS UP MORE THAN USUAL DURING OPERATION. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATING THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER HANDPIECE. IT WAS CONFIRMED THAT THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307645 IPC® HANDPIECE - INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC XOMED INC. 1845000 208868102 00613994933713

    Patients

    Seq Age Sex Outcome Treatment
    1