BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 8686810 · Received June 11, 2019

    Report

    Report Number
    9710107-2019-00243
    Event Type
    Malfunction
    Date Received
    June 11, 2019
    Report Date
    July 18, 2019
    Manufacturer
    GIVEN IMAGING LTD., YOQNEAM
    Product Code
    FFT
    UDI-DI
    07290101361688
    PMA / PMN Number
    K102543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    ACCORDING TO THE REPORTER, THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR THE PROCEDURE AND AN ENDOSCOPY HAD BEEN PERFORMED PRIOR TO THE PROCEDURE AND SHOWED THE ESOPHAGUS TO BE NORMAL. LUBRICATION WAS USED TO FACILITATE PLACEMENT OF THE CAPSULE AND SCOPE WAS USED TO DETERMINE CAPSULE PLACEMENT. HOWEVER, THE CAPSULE FAILED TO ATTACH ON THE PATIENT'S ESOPHAGUS. NO INTERVENTION WAS REQUIRED. THERE WAS NO PATIENT HARM AND REPEAT PROCEDURE WAS NOT PERFORMED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR THE PROCEDURE AND AN ENDOSCOPY HAD BEEN PERFORMED PRIOR TO THE PROCEDURE AND SHOWED THE ESOPHAGUS TO BE NORMAL. LUBRICATION WAS USED TO FACILITATE PLACEMENT OF THE CAPSULE AND SCOPE WAS USED TO DETERMINE CAPSULE PLACEMENT. HOWEVER, THE CAPSULE FAILED TO ATTACH ON THE PATIENT'S ESOPHAGUS. NO INTERVENTION WAS REQUIRED. A REPEAT PROCEDURE WAS NOT PERFORMED AS NEW CAPSULE WAS USED. THE CUSTOMER TESTED THE PLACEMENT SUCTION EQUIPMENT AND IT WAS WORKING APPROPRIATELY. THERE WAS NO PATIENT AND USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479863 BRAVO ELECTRODE, PH, STOMACH FFT GIVEN IMAGING LTD., YOQNEAM FGS-0313 07290101361688

    Patients

    Seq Age Sex Outcome Treatment
    1