BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL 3334800 VISAO 80K HANDPIECE

    MDR report key: 2903419 · Received January 9, 2013

    Report

    Report Number
    1045254-2013-00018
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 10, 2012
    Manufacturer
    MEDTRONIC INC.
    Product Code
    ERL
    PMA / PMN Number
    K011321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE DEVICE WAS NOT RETURNED. METHOD: THE DEVICE WAS NOT RETURNED AND NO EVALUATION COULD BE PERFORMED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED (B)(4) 2012. DEVICE ANALYSIS: THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. NO FAULT WAS FOUND WITH THE DEVICE. THE UNIT WAS TESTED AND PASSED ALL MANUFACTURING SPECIFICATIONS. THE TEMPERATURES WERE MEASURED AND NEVER EXCEEDED 110 F. BASED ON ANALYSIS, THE MOST LIKELY CAUSE OF THIS EVENT WAS A USABILITY ISSUE, SUCH AS BLADE/BUR INSTALLATION, COOLANT ISSUE, OR SPECIFIC DUTY CYCLE USED.

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED THAT A VISAO HANDPIECE WAS OVERHEATING. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10764 DRILL 3334800 VISAO 80K HANDPIECE DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC INC. 3334800 38536800

    Patients

    Seq Age Sex Outcome Treatment
    1