BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1912242 · Received November 18, 2010

    Report

    Report Number
    9710107-2010-00777
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 18, 2010
    Manufacturer
    GIVEN IMAGING LTD.
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED ON A BRAVO PH CAPSULE THAT FAILED TO DETACH FROM DELIVERY SYSTEM. THE PATIENT WAS NOT INJURED FOLLOWING THE PROCEDURE. CUSTOMER STATES THAT THE PHYSICIAN USED THE EMERGENCY RELEASE PROCEDURE AND IT STILL DID NOT RELEASE. THEY DID NOT SEE THE SILVER WIRE TO PULL IT SO THEY WOUND UP CUTTING THE GREEN WIRE, STILL DID NOT RELEASE. EVENTUALLY THE CAPSULE WAS RELEASED WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO BRAVO PH CAPSULE FFT GIVEN IMAGING LTD. BRAVO PH CAPSULE 13700Q

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention