BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO PH RECDR

    MDR report key: 6010768 · Received October 7, 2016

    Report

    Report Number
    9710107-2016-01038
    Event Type
    Malfunction
    Date Received
    October 7, 2016
    Report Date
    April 11, 2018
    Manufacturer
    GIVEN LTD (ISRAEL)
    Product Code
    FFT
    PMA / PMN Number
    K102543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THOUGH THE RECORDER WAS NOT RECEIVED FOR EVALUATION, THE STUDY WAS PROVIDED FOR REVIEW. BASED ON THE DATA THAT WAS COLLECTED DURING THE PROCEDURE, THE STUDY WAS 30:58:42 OF AN ANTICIPATED 48 OR 96 HOURS. PH VALUES ARE NORMAL THROUGHOUT THE DURATION OF THE STUDY. DUE TO THE FACT THAT THE RECORDER WAS NOT RETURNED AND ONLY THE STUDY WAS PROVIDED, THE CAUSE OF THE SHORT STUDY COULD NOT BE RELIABLY DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE PRODUCT WAS RELEASED MEETING FINISHED PRODUCT SPECIFICATION. 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, DURING AN ESOPHAGEAL PROCEDURE, THE BRAVO CAPSULE DETACHED PRIOR TO THE END OF THE PROCEDURE. A REPEAT PROCEDURE WAS NECESSARY. NO OTHER KNOWN ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662612 BRAVO PH RECDR ELECTRODE, PH, STOMACH FFT GIVEN LTD (ISRAEL) FGS-0450 31516Q

    Patients

    Seq Age Sex Outcome Treatment
    1