BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE - INDIGO¿ DRILL

    MDR report key: 6045514 · Received October 20, 2016

    Report

    Report Number
    1045254-2016-00351
    Event Type
    Malfunction
    Date Received
    October 20, 2016
    Date of Event
    September 15, 2016
    Report Date
    September 26, 2016
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: -- 1845020: ATTACHMENT 1845020 INDIGO OTOL ANGLED, S/N (B)(4), LOT 206302264, MANUFACTURED DATE: 11/06/2012 -- 1845010: ATTACHMENT 1845010 INDIGO OTOL STRAIGHT, S/N (B)(4), LOT 206301859, MANUFACTURED DATE: 11/06/2012 -- 1845030: TUBING 1845030 INDIGO 5PK. PRODUCT EVALUATION: ANALYSIS RESULTS NOT AVAILABLE; THE DEVICES HAVE NOT BEEN RETURNED. 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

    DATE OF THIS REPORT: 09/26/2016. UDI: (B)(4). IS THE DEVICE AVAILABLE FOR EVALUATION? YES. RECEIVED: 11/23/2016. DATE MANUFACTURER RECEIVED: 12/1/2016. PRODUCT EVALUATION: THE INDIGO DRILL (1845000), ANGLED ATTACHMENT (1845020) AND STRAIGHT ATTACHMENT (1845010), WERE RETURNED AND TESTED TOGETHER TO CHECK FOR OVERHEATING AND/OR MALFUNCTION. SERVICE AND REPAIR PERFORMED A 1 MINUTE PRE-REPAIR TEMPERATURE CHECK AND AFTER RUNNING THE INDIGO DRILL FOR 1 MINUTE THE UNIT MEASURED 76.7 F. THE UNIT WAS CLEANED AND TESTED TO SPECIFICATIONS. NO FAULT WAS FOUND WITH THE DEVICE. SERVICE AND REPAIR PERFORMED A 1 MINUTE PRE-REPAIR TEMPERATURE CHECK AND AFTER RUNNING THE ANGLED ATTACHMENT FOR 1 MINUTE THE UNIT MEASURED 74.1 F. THE UNIT WAS CLEANED AND TESTED TO SPECIFICATIONS. SERVICE AND REPAIR PERFORMED A 1 MINUTE PRE-REPAIR TEMPERATURE CHECK AND AFTER RUNNING THE STRAIGHT ATTACHMENT FOR 1 MINUTE THE UNIT MEASURED 75.8 F. THE UNIT WAS CLEANED AND TESTED TO SPECIFICATIONS. (B)(4).

    Additional Manufacturer Narrative · 1

    DATE OF THIS REPORT: (B)(6) 2016: UDI #: (B)(4). DATE RECEIVED BY MANUFACTURER: DECEMBER 14, 2016. PRODUCT EVALUATION: (B)(4): TUBING (B)(4) INDIGO: WHEN RECEIVED FOR ANALYSIS THERE WAS FLUID INSIDE THE TUBING SET. VISUALLY, THERE WAS NO DAMAGE OR ANOMALIES IN THE CONSTRUCTION OF THE DEVICE THAT WOULD HAVE RESULTED IN THE REPORTED EVENT. THE SLIDE CLAMP THAT PREVENTS IRRIGATION FLOW WAS ENGAGED AS RECEIVED; IT WAS DISENGAGED FOR THE ANALYSIS. FUNCTIONALLY, 10CC OF WATER WAS INJECTED INTO THE TUBING SET AND IRRIGATION FLOWED FREELY OUT OF THE TIP.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING THE PROCEDURE "THEY DID NOT PRIME THE TUBING WITH THE IPC. THEY THEN HELD THEIR FOOT ON THE FOOT PEDAL TO RUN THE IRRIGATION FLUID THROUGH THE TUBING. THE FLUID NEVER CAME OUT (THEY DETERMINED THE TUBING WAS NOT FUNCTIONAL). WHILE TRYING TO GET THE IRRIGATION FLUID TO RUN THROUGH THE DRILL HEATED UP AND WAS REPORTED TO HAVE BURNED THE FELLOW AND THEN THE SURGEON'S HAND." IT WAS CONFIRMED THAT THERE WAS NO BURN, "IT WAS JUST SORE AND SLIGHTLY RED FOR A FEW HOURS"; THE DRILL HEATED UP IN LESS THAN 1 MINUTE. NO INTERVENTIONS WERE REQUIRED, THERE WAS NO SERIOUS INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695381 IPC® HANDPIECE - INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC XOMED INC. 1845000 206315728

    Patients

    Seq Age Sex Outcome Treatment
    1