BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEAL BIOPSY VALVE CAP

    MDR report key: 5088371 · Received September 11, 2015

    Report

    Report Number
    3007591333-2015-00043
    Event Type
    Malfunction
    Date Received
    September 11, 2015
    Date of Event
    August 10, 2015
    Report Date
    September 11, 2015
    Manufacturer
    ENDOCHOICE INC.
    Product Code
    OCX
    PMA / PMN Number
    K133734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT RUBBER PIECES FORM THE DISPOSABLE BIOPSY VALVE CAP WERE FRAGMENTING INTO THE ENDOSCOPE CHANNEL WHEN THE BIOSPY FORCEPS WERE INSERTED INTO THE ENDOSCOPE. THERE WAS NO REPORT OF INJURY OR OTHER NEGATIVE HEALTH CONSEQUENCES TO ANY PATIENT. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION THAT THE MEDICAL DEVICE CAUSE OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601203 SEAL BIOPSY VALVE CAP OCX ENDOCHOICE INC. NA NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1