BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE ATTACHMENT - INDIGO¿ DRILL

    MDR report key: 6487380 · Received April 12, 2017

    Report

    Report Number
    1045254-2017-00115
    Event Type
    Malfunction
    Date Received
    April 12, 2017
    Date of Event
    March 11, 2017
    Report Date
    March 18, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    UDI-DI
    00613994933690
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICE: #3 REPORTED ON INITIAL MDR: 1845020: S/N (B)(4), LOT 209648538 MANUFACTURED: 2015-07-15 (B)(4). 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

    PRODUCT EVALUATION: -- 1845020 INDIGO OTOL ANGLED, S/N (B)(4): EVALUATION OF THE DEVICE FOUND THAT THE LASER MARKINGS HAVE FADED AND THE LOCKING MECHANISM IS NON-FUNCTIONAL. -- 1845020 INDIGO OTOL ANGLED, S/N (B)(4): EVALUATION OF THE DEVICE FOUND THAT THE BEARINGS ARE BROKEN AND THE LASER MARKINGS HAVE FADED. -- 1845020 INDIGO OTOL ANGLED, S/N (B)(4): EVALUATION OF THE DEVICE FOUND THAT THE TUBE BEARINGS ARE CORRODED AND THE LASER MARKINGS ARE FADED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: A 1845020: ATTACHMENT 1845020 INDIGO OTOL ANGLED, S/N (B)(4), LOT 211695293, UDI # (B)(4), MANUFACTURED 2016-08-03. A 1845020: ATTACHMENT 1845020 INDIGO OTOL ANGLED, S/N AND LOT UNKNOWN. A 1845000: DRILL 1845000 INDIGO HIGH SPEED OTOLOGIC, S/N (B)(4), LOT 209163325, UDI # (B)(4), MANUFACTURED 2015-02-04.PRODUCT EVALUATION: ANALYSIS RESULTS NOT AVAILABLE; DEVICES NOT RETURNED FOR EVALUATION. 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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED: THE USER REPORTS THAT THERE IS ALSO A "RUSTING TYPE COLOUR ON THE OUTSIDE AND INSIDE THE DISTAL SHAFT, AND THEY ARE FREQUENTLY HAVING TO REPLACE ANGLED ATTACHMENTS.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS THAT "BURRS ARE GETTING STUCK IN ATTACHMENTS AND PROVING DIFFICULT TO REMOVE. EXCESSIVE OVERHEATING OF DRILL. GRATING SOUND PRESENT WHEN USING DRILL, DISAPPEARS WHEN NEW ANGLED ATTACHMENT IS USED." THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268905 IPC® HANDPIECE ATTACHMENT - INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC XOMED INC. 1845020 211695293 00613994933690

    Patients

    Seq Age Sex Outcome Treatment
    1