BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE ATTACHMENT - INDIGO¿ DRILL

    MDR report key: 4763553 · Received May 11, 2015

    Report

    Report Number
    1625507-2015-00020
    Event Type
    Malfunction
    Date Received
    May 11, 2015
    Date of Event
    April 12, 2015
    Report Date
    April 17, 2015
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBE
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT MEDICAL PRODUCTS: 1845020: ATTACHMENT INDIGO OTOL ANGLED, SERIAL # (B)(4), LOT #207262552, MANUFACTURED DATE ¿ AUG/07/2013. 1845020: ATTACHMENT INDIGO OTOL ANGLED, SERIAL #(B)(4), LOT # 207262552, MANUFACTURED DATE ¿AUG/07/2013. 1845000: DRILL INDIGO HIGH SPEED OTOLOGIC, SERIAL # (B)(4). (B)(4). THE THREE ATTACHMENTS WERE RECEIVED AT XOMED FOR PRE-REPAIR EVALUATION. PRE-REPAIR TEMPERATURE TESTING AT ONE MINUTE FOUND THE INDIGO ANGLED ATTACHMENT (PART # 1845020, SN# (B)(4)) MEASURED: NOSE - 75 DEGREES F, MIDDLE - 78 DEGREES F, REAR 81 - DEGREES F. THE COLLET WOULD NOT HOLD THE BUR. OVERHEATING COULD NOT BE DUPLICATED OR CONFIRMED. PRE-REPAIR TEMPERATURE TESTING FOR THE INDIGO ATTACHMENT (PART # 1845010, SN# (B)(4)) COULD NOT BE COMPLETED AS THE ATTACHMENT WOULD NOT SIT RIGHT ON THE DRILL. OVERHEATING COULD NOT BE DUPLICATED OR CONFIRMED. PRE-REPAIR TEMPERATURE TESTING AT ONE MINUTE FOUND THE INDIGO ANGLED ATTACHMENT (PART # 1845020, SN# (B)(4)) MEASURED: NOSE - 74 DEGREES F, MIDDLE - 74 DEGREES F, REAR - 73 DEGREES F. THE COLLET WOULD NOT HOLD THE BUR. THE OVERHEATING COULD NOT BE DUPLICATED OR CONFIRMED. ALL THREE ATTACHMENTS WERE SENT TO FORT WORTH MPSS FOR REPAIR.

    Additional Manufacturer Narrative · 1

    FURTHER TESTING FOUND THE FOLLOWING: PRODUCT ID#1845020, SN# (B)(4), LOT# 207262552 ¿ AFTER RUNNING FOR 5 MINUTES THE DEVICE TEMPERATURE MEASURED 136.8 DEGREES F. EVALUATION OF THE DEVICE FOUND THAT THE BEARINGS AND GEARS WERE CORRODED. PRODUCT ID#1845010, SN# (B)(4), LOT# 207255663 ¿ AFTER RUNNING FOR 5 MINUTES, THE DEVICE TEMPERATURE MEASURED 118.6 DEGREES F. EVALUATION OF THE DEVICE FOUND THAT THE BEARINGS WERE WORN. PRODUCT ID#1845020 SN# (B)(4), LOT# 207262552 ¿ AFTER RUNNING FOR 5 MINUTES THE DEVICE TEMPERATURE MEASURED 128.3 DEGREES F. EVALUATION OF THE DEVICE FOUND THAT THE BEARINGS AND GEARS WERE CORRODED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE ATTACHMENTS WERE OVERHEATING AND CANNOT SECURE THE BUR PROPERLY. LUBRICATION PERFORMED AS INDICATED IN USER'S MANUAL. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307173 IPC® HANDPIECE ATTACHMENT - INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MDT POWERED SURGICAL SOLUTIONS 1845010 207255663

    Patients

    Seq Age Sex Outcome Treatment
    1