BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHTSHOT® M4 MICRODEBRIDER

    MDR report key: 4063624 · Received September 5, 2014

    Report

    Report Number
    1045254-2014-00213
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Report Date
    August 12, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ERL
    PMA / PMN Number
    K041413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). PRODUCT EVALUATION: WHEN RECEIVED FOR ANALYSIS THE PRE-REPAIR TEMPERATURE TESTING COULD NOT BE COMPLETED; THE UNIT WAS NOT RUNNING WHEN RECEIVED. THE MOTOR/CABLE BEARINGS, SEALS AND OTHER PARTS WERE REPLACED DUE TO SALINE CAUSING CORROSION. THE ITEM WAS TESTED AND PASSED TO MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS OVERHEATING. THERE WAS NO PATIENT IMPACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545000 STRAIGHTSHOT® M4 MICRODEBRIDER DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED INC. 1898200T 36946800

    Patients

    Seq Age Sex Outcome Treatment
    1