BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE - INDIGO¿ DRILL

    MDR report key: 6739596 · Received July 25, 2017

    Report

    Report Number
    1045254-2017-00254
    Event Type
    Malfunction
    Date Received
    July 25, 2017
    Date of Event
    June 28, 2017
    Report Date
    June 28, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    UDI-DI
    00613994933713
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 1845000 (DRILL, INDIGO HIGH SPEED OTOLOGIC); SERIAL NUMBER - (B)(4); LOT NUMBER - 209489570; MANUFACTURED DATE - APR/24/2015; UDI NUMBER - (B)(4); 510K - K081475 1845000 (DRILL, INDIGO HIGH SPEED OTOLOGIC); SERIAL NUMBER - (B)(4); LOT NUMBER - 209489570; MANUFACTURED DATE - APR/24/2015; UDI NUMBER - (B)(4); 510K - K081475. THE DRILLS HAVE BEEN RECEIVED. THE PRODUCT ANALYSES HAVE NOT YET BEEN PERFORMED. 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

    THE 1845000 (SERIAL (B)(4)): THE PRODUCT ANALYSIS INDICATES THE DEVICE WAS RECEIVED IN GOOD CONDITION. THE REPORTED ISSUE OF OVERHEATING COULD NOT BE CONFIRMED. THE ONE-MINUTE PRE-REPAIR TEMPERATURE TEST RESULTS ARE AS FOLLOWS: 87 DEGREES F AT T1 AND 83 DEGREES F AT T2. THE HANDPIECE WAS SUCCESSFULLY TESTED TO MANUFACTURING SPECIFICATIONS. THE 1845000 (SERIAL (B)(4)): THE PRODUCT ANALYSIS INDICATES THE DEVICE WAS RECEIVED IN GOOD CONDITION. THE REPORTED ISSUE OF OVERHEATING COULD NOT BE CONFIRMED. THE ONE-MINUTE PRE-REPAIR TEMPERATURE TEST RESULTS ARE AS FOLLOWS: 83 DEGREES F AT T1 AND 82 DEGREES F AT T2. THE HANDPIECE WAS SUCCESSFULLY TESTED TO MANUFACTURING SPECIFICATIONS. THE 1845000 (SERIAL (B)(4)): THE PRODUCT ANALYSIS INDICATES THE DEVICE WAS RECEIVED IN GOOD CONDITION. THE REPORTED ISSUE OF OVERHEATING COULD NOT BE CONFIRMED. THE ONE-MINUTE PRE-REPAIR TEMPERATURE TEST RESULTS ARE AS FOLLOWS: 87 DEGREES F AT T1 AND 82 DEGREES F AT T2. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING USE, THREE INDIGO HANDPIECE/DRILL HANDLES GOT TOO HOT TO HOLD. A DAMP SWAB WAS WRAPPED AROUND THE HANDLES. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520443 IPC® HANDPIECE - INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC XOMED INC. 1845000 209455624 00613994933713

    Patients

    Seq Age Sex Outcome Treatment
    1