BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEAL

    MDR report key: 6926092 · Received October 7, 2017

    Report

    Report Number
    3007591333-2017-00057
    Event Type
    Malfunction
    Date Received
    October 7, 2017
    Date of Event
    September 19, 2017
    Report Date
    October 6, 2017
    Manufacturer
    ENDOCHOICE, INC.
    Product Code
    OCX
    PMA / PMN Number
    K111821
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICES WERE NOT RETURNED TO THE MANUFACTURER. NO FURTHER EVALUATION IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    THE COMPLAINANT STATED THAT SMALL FRAGMENTS OF THE BIOPSY VALVE ENTERED THE PATIENT DURING A FLEXIBLE ENDOSCOPY CASE. NO INTERVENTION WAS DEEMED NECESSARY, AND NO OTHER NEGATIVE HEALTH CONSEQUENCE TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705875 SEAL BIOPSY VALVE FOR FLEXIBLE ENDOSCOPY OCX ENDOCHOICE, INC. SBC-365 170522

    Patients

    Seq Age Sex Outcome Treatment
    1