BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4

    MDR report key: 6046621 · Received October 21, 2016

    Report

    Report Number
    1045254-2016-00353
    Event Type
    Injury
    Date Received
    October 21, 2016
    Date of Event
    September 27, 2016
    Report Date
    September 27, 2016
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ERL
    PMA / PMN Number
    K041413
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICE: 1884004HR: BLADE 1884004HR TRICUT 5PK M4 4MM ROTATA. INITIAL USE OF DEVICE 510K: EXEMPT PRO CODE: EQJ. PRODUCT EVALUATION: ANALYSIS RESULTS NOT AVAILABLE. THERE WAS NO MALFUNCTION REPORTED FOR EITHER DEVICE; THE HANDPIECE IS STILL IN USE AND THE BLADE WAS DISCARDED FOLLOWING THE PROCEDURE. 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SINUS PROCEDURE THE PATIENT SUFFERED AN ANTERIOR ETHMOID ARTERY INJURY WHICH LED TO BLEEDING INTO THE EYE. TO RELIEVE THE PRESSURE ON THE EYE CAUSED BY THE BLEEDING, A LATERAL CANTHOTOMY WAS PERFORMED BY AN OPHTHALMOLOGIST. THE PATIENT'S CURRENT STATUS IS WELL AND HER VISION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698421 IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4 DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED INC. 1898200T 58096000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention