BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO PH CAPSULE DELIVERY DEV, 1-PK

    MDR report key: 6090029 · Received November 9, 2016

    Report

    Report Number
    9710107-2016-01080
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Report Date
    October 19, 2016
    Manufacturer
    GIVEN LTD (ISRAEL)
    Product Code
    FFT
    PMA / PMN Number
    K102543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    MANUFACTURE REFERENCE NUMBER: (B)(4). EVALUATION SUMMARY: ONE DELIVERY SYSTEM WAS RECEIVED FOR EVALUATION AND INVESTIGATED VISUALLY FOR EXTERNAL DAMAGE. THE DELIVERY SYSTEM WAS DISINFECTED AND THE LOT NUMBER AND ID# MATCHED THE INFORMATION PROVIDED BY THE INITIAL REPORTED. THE DELIVERY SYSTEM WAS NOT BENT AND THE PLUNGER WAS NOT BROKEN. THE WIRE GUIDE WAS BENT. THE EMERGENCY PROCEDURE WAS NOT IMPLEMENTED. THE DELIVERY SYSTEM DID NOT HAVE ANY OTHER VISIBLE DAMAGE. PER THE CONDITION IN WHICH THE DEVICE WAS RECEIVED, THE DELIVERY SYSTEM AND CAPSULE SEEMED TO BE FUNCTIONING PER SPECIFICATION. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE PROVIDED LOT / SERIAL NUMBER WAS COMPLETED AND INDICATES ALL PARAMETERS AND ACCEPTANCE CRITERIA FOR ENTRIES POTENTIALLY PERTINENT TO THE REPORTED EVENT WERE WITHIN SPECIFIED LIMITS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING AN ESOPHAGEAL PROCEDURE, THE CAPSULE FAILED TO ATTACH TO THE PATIENT'S ESOPHAGUS. A REPEAT BRAVO PROCEDURE WAS NOT CONFIRMED. THERE WAS NO HARM TO THE PATIENT. NO INTERVENTION WAS REQUIRED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR PROCEDURE ITSELF THAT MAY HAVE LED TO THIS EVENT. AN ENDOSCOPY WAS NOT PERFORMED PRIOR TO THE PROCEDURE. THE BRAVO USER HAS BEEN USING THIS PROCEDURE FOR OVER FIVE YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740098 BRAVO PH CAPSULE DELIVERY DEV, 1-PK ELECTRODE, PH, STOMACH FFT GIVEN LTD (ISRAEL) FGS-0313 31606Q

    Patients

    Seq Age Sex Outcome Treatment
    1