BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXILLARY OSTIOUM SEEKER PROBE

    MDR report key: 6571719 · Received May 17, 2017

    Report

    Report Number
    2951238-2017-00356
    Event Type
    Malfunction
    Date Received
    May 17, 2017
    Date of Event
    April 12, 2017
    Report Date
    May 17, 2017
    Manufacturer
    EXPLORENT CHIRURGISCHE INSTRUMENTE GMBH
    Product Code
    KAK
    PMA / PMN Number
    PEXEMPT-KAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCED DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE OR IF THE DEVICE IS RETURNED TO OLYMPUS FOR EVALUATION AT A LATER DATE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT A PART OF THE DEVICE BROKE AND FELL INTO A PATIENT DURING A (FESS) FUNCTIONAL ENDOSCOPIC SINUS SURGERY PROCEDURE. THE PART OF THE DEVICE WAS NOT SPECIFIED. THE DEVICE FRAGMENT WAS RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT. NO PATIENT/USER INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355305 MAXILLARY OSTIOUM SEEKER PROBE MAXILLARY OSTIOUM SEEKER PROBE KAK EXPLORENT CHIRURGISCHE INSTRUMENTE GMBH 70230771 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1