BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO PH CAPSULE DELIEVERY DEV, 1-PK

    MDR report key: 6098438 · Received November 14, 2016

    Report

    Report Number
    9710107-2016-01082
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    September 15, 2016
    Report Date
    October 21, 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

    (B)(4). EVALUATION SUMMARY: ONE DELIVERY SYSTEM AND CAPSULE WERE RECEIVED FOR EVALUATION AND INVESTIGATED VISUALLY FOR EXTERNAL DAMAGE. THE DELIVERY SYSTEM AND CAPSULE WERE DISINFECTED AND THE LOT NUMBER AND ID# MATCHED THE INFORMATION PROVIDED BY THE INITIAL REPORTED. THE TROCAR NEEDLE WAS ADVANCED. THE DELIVERY SYSTEM WAS NOT BENT AND THE PLUNGER WAS NOT BROKEN. THE EMERGENCY PROCEDURE WAS NOT IMPLEMENTED AND THE CAPSULE ELECTRODES WERE OKAY. 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 FELL INTO THE PATIENT'S STOMACH WHEN DEPLOYED. THERE WAS NO HARM TO THE PATIENT. A REPEAT BRAVO PROCEDURE WAS PERFORMED. INTERVENTION WAS NOT REQUIRED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR THE PROCEDURE ITSELF THAT MAY HAVE LED TO THIS EVENT. AN ENDOSCOPY WAS PERFORMED PRIOR TO THE BRAVO PROCEDURE AND THE ESOPHAGUS APPEARED TO BE NORMAL. THE BRAVO USER HAS BEEN USING THIS PROCEDURE FOR SIX MONTHS. LUBRICANT WAS NOT USED TO FACILITATE CAPSULE PLACEMENT. THE DEVICE OPERATOR IS UNSURE OF WHAT WOULD HAVE CAUSED THE CAPSULE TO ATTACH/DETACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750554 BRAVO PH CAPSULE DELIEVERY DEV, 1-PK ELECTRODE, PH, STOMACH FFT GIVEN LTD (ISRAEL) FGS-0313 31606Q

    Patients

    Seq Age Sex Outcome Treatment
    1