BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4

    MDR report key: 4856485 · Received June 19, 2015

    Report

    Report Number
    1045254-2015-00211
    Event Type
    Malfunction
    Date Received
    June 19, 2015
    Date of Event
    May 24, 2015
    Report Date
    May 27, 2015
    Manufacturer
    MEDTRONIC, INC
    Product Code
    ERL
    PMA / PMN Number
    K041413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT MEDICAL PRODUCTS: CONSOLE 1898001 IPC, 510K: K081277. (B)(4).

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER AND LOT NUMBER FOR THE REPORTED DEVICE (M4 HANDPIECE) . THE SERIAL NUMBER FOR THE CONCOMITANT DEVICE (IPC) IS (B)(4), LOT # 209092786, MANUFACTURED DATE 2014-12-22THIS INFORMATION WAS RECEIVED BY MEDTRONIC XOMED ON JUNE 22, 2015. THE MANUFACTURED DATE FOR THE REPORTED DEVICE IS 2015-05-01.

    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 DURING ENDOSCOPIC SINUS SURGERY (ESS) THE SURGITRON, IPC, AND M4 WERE PLUGGED INTO THE SAME OUTLET. WHEN THE SURGITRON WAS USED, IT CAUSED THE HANDPIECE TO ACTIVATE UNEXPECTEDLY. THERE WAS NO IMPACT. ONCE THE DEVICES WERE ASSIGNED TO THEIR OWN OUTLETS, THE PROBLEM DID NOT RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401549 IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4 DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC, INC 1898200T 209103219

    Patients

    Seq Age Sex Outcome Treatment
    1