BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE - INDIGO¿ DRILL

    MDR report key: 5508865 · Received March 17, 2016

    Report

    Report Number
    1045254-2016-00076
    Event Type
    Malfunction
    Date Received
    March 17, 2016
    Report Date
    February 23, 2016
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT MEDICAL PRODUCTS: INDIGO DRILL #1845000, SN# (B)(4), LOT# 210240093; INDIGO DRILL #1845000, SN# (B)(4), LOT# 210150121; INDIGO ATTACHMENT #1845020, SN# (B)(4), LOT# 210302642; INDIGO ATTACHMENT #1845020, SN# (B)(4), LOT# 208777604; INDIGO ATTACHMENT #1845020, SN# (B)(4), LOT# 210302644. (B)(4). THE DEVICES HAVE NOT BEEN RECEIVED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVAL: 03/24/2016. THE DEVICES WERE RETURNED AND ANALYZED AS FOLLOWS: INDIGO DRILL #1845000 SN# (B)(4) LOT# 208868102: ANALYSIS FOUND NO FUNCTIONAL FAULT WITH THE DEVICE AND THE REPORTED OVERHEATING WAS NOT CONFIRMED. TEMPERATURE TEST AT ONE MINUTE WAS 76.1°F. VISUAL ANALYSIS FOUND THE DEVICE IS DISCOLORED. THE DRILL WAS CLEANED AND TESTED TO PRODUCT SPECIFICATIONS AND RETURNED TO CUSTOMER. INDIGO DRILL #1845000 SN# (B)(4) LOT# 208796687: ANALYSIS FOUND NO FUNCTIONAL FAULT WITH THE DEVICE AND THE REPORTED OVERHEATING WAS NOT CONFIRMED. TEMPERATURE TEST AT ONE MINUTE WAS 76°F. VISUAL ANALYSIS FOUND THE DEVICE IS DISCOLORED. THE DRILL WAS CLEANED AND TESTED TO PRODUCT SPECIFICATIONS AND RETURNED TO CUSTOMER. INDIGO DRILL #1845000 SN# (B)(4) LOT# 209592797: ANALYSIS FOUND NO FUNCTIONAL FAULT WITH THE DEVICE AND THE REPORTED OVERHEATING WAS NOT CONFIRMED. TEMPERATURE TEST AT ONE MINUTE WAS 75.7°F. VISUAL ANALYSIS FOUND THE DEVICE IS DISCOLORED. THE DRILL WAS CLEANED AND TESTED TO PRODUCT SPECIFICATIONS AND RETURNED TO CUSTOMER. INDIGO ATTACHMENT #1845020 SN# (B)(4) LOT# 209752490: ANALYSIS FOUND NO FUNCTIONAL FAULT WITH THE DEVICE AND THE REPORTED OVERHEATING WAS NOT CONFIRMED. TEMPERATURE TEST AT ONE MINUTE WAS 74.1°F. THE DEVICE WAS CLEANED AND TESTED TO PRODUCT SPECIFICATIONS AND RETURNED TO CUSTOMER. INDIGO ATTACHMENT #1845020 SN# (B)(4) LOT# 208777604: ANALYSIS FOUND NO FUNCTIONAL FAULT WITH THE DEVICE AND THE REPORTED OVERHEATING WAS NOT CONFIRMED. TEMPERATURE TEST AT ONE MINUTE WAS 75.8°F. THE DEVICE WAS CLEANED AND TESTED TO PRODUCT SPECIFICATIONS AND RETURNED TO CUSTOMER. INDIGO ATTACHMENT #1845020 SN# (B)(4) LOT# 209797053: ANALYSIS FOUND NO FUNCTIONAL FAULT WITH THE DEVICE AND THE REPORTED OVERHEATING WAS NOT CONFIRMED. TEMPERATURE TEST AT ONE MINUTE WAS 76.8°F. THE DEVICE WAS CLEANED AND TESTED TO PRODUCT SPECIFICATIONS AND RETURNED TO CUSTOMER. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRILLS AND ATTACHMENTS WERE NOT WORKING PROPERLY AND HEATING UP. IT WAS NOTED THAT NONE OF THE ISSUES OCCURRED DURING A SURGERY. THERE WAS NO REPORT OF INJURY AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164107 IPC® HANDPIECE - INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC XOMED INC. 1845000 208868102

    Patients

    Seq Age Sex Outcome Treatment
    1