BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE - INDIGO¿ DRILL

    MDR report key: 6684459 · Received July 3, 2017

    Report

    Report Number
    1045254-2017-00216
    Event Type
    Malfunction
    Date Received
    July 3, 2017
    Date of Event
    May 1, 2017
    Report Date
    March 15, 2018
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    UDI-DI
    00613994933713
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE - DATE OF EVENT (B)(6) 2017 WAS SUBMITTED IN THE INITIAL MDR. IN THIS EVENT DATE ONLY THE MONTH AND YEAR IS VALID, THE EXACT DATE IS UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. 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

    CONCOMITANT MEDICAL PRODUCTS: 1845010: INDIGO OTOL STRAIGHT ATTACHMENT, SERIAL # (B)(4), LOT # 206377037, MANUFACTURED DATE ¿ NOV/27/2012, 510(K) # K081475, (B)(4): INDIGO OTOL ANGLED ATTACHMENT, SERIAL # (B)(4), LOT # 206315577, MANUFACTURED DATE - NOV/15/2012, 510(K) # K081475, UDI # (B)(4). EVALUATION WAS NOT PERFORMED; PRODUCTS 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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED CONFIRMED THE SURGERY WAS NOT POSTPONED, IT WAS COMPLETED. A COMPETITOR DRILL (CONMED DRILL) WAS USED TO COMPLETE THE SURGERY. OTHER PROCEDURES WERE DELAYED UNTIL A REPLACEMENT MEDTRONIC DRILL WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED: IT HAS BEEN CONFIRMED THAT THE DRILL AND ATTACHMENTS ON THIS REPORT DID NOT MALFUNCTION. THESE DEVICES WERE REPLACEMENTS; THIS REPORT WAS CREATED IN ERROR.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT PRE-OPERATIVE THE HANDPIECE HEATED UP INSTANTLY, WITHIN A MINUTE. THE HAND PIECE GOT TOO HOT TO EVEN HOLD IN DOCTOR'S HAND. THE ANGLED AND STRAIGHT ATTACHMENT DID NOT HEAT UP. THE SURGERY WAS POSTPONED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465321 IPC® HANDPIECE - INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC XOMED INC. 1845000 206517172 00613994933713

    Patients

    Seq Age Sex Outcome Treatment
    1