BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4

    MDR report key: 5224618 · Received November 15, 2015

    Report

    Report Number
    1045254-2015-00373
    Event Type
    Malfunction
    Date Received
    November 15, 2015
    Date of Event
    October 14, 2015
    Report Date
    October 15, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ERL
    PMA / PMN Number
    K041413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: (1) CONSOLE XPS 3000 2 PUMP (1897102); SN: (B)(4); LOT: 44921800; DATE OF MANUFACTURE: JUNE 6, 2006; CUSTOMER REFUSED DEVICE RETURN; 510K: K002224. (B)(4). IN RESPONSE TO MEDTRONIC¿S REQUEST FOR DEVICE RETURN, NO DEVICES WERE RECEIVED FOR EVALUATION¿AS THE FACILITY HAS REFUSED RETURN OF BOTH DEVICES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A IGS M4 MICRODEBRIDER "BECAME HOT AND STOPPED RUNNING" INTRAOPERATIVELY DURING A POLYP REMOVAL SINUS CASE. THIS IS THE ONLY INFORMATION PROVIDED AND THERE WAS ALSO NO REPORT OF PATIENT IMPACT OR INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754705 IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4 DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED INC. 1898200T 44824800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown *SEE H10