BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO PH CAPSULE DELIVERY DEVICE

    MDR report key: 4999219 · Received August 11, 2015

    Report

    Report Number
    9710107-2015-00212
    Event Type
    Malfunction
    Date Received
    August 11, 2015
    Date of Event
    July 28, 2015
    Report Date
    August 10, 2015
    Manufacturer
    GIVEN IMAGING LTD.
    Product Code
    FFT
    PMA / PMN Number
    K102543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE INDICATED THAT THE INCIDENT UNIT WILL BE RETURNING TO THE MFR FOR EVAL WHEN ADD'L INFO PERTINENT TO THE INCIDENT PRESENTS ITSELF, A F/U REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ONE DELIVERY SYSTEM WAS RETURNED TO MEDTRONIC FOR EVALUATION. THE CAPSULE WAS NOT RETURNED. THE DELIVERY SYSTEM WAS INVESTIGATED VISUALLY FOR EXTERNAL DAMAGE. THERE WERE NO SIGNS OF BLOOD OR TISSUE ON THE DEVICE. THE DELIVERY SYSTEM WAS NOT BENT AND THE PLUNGER WAS NOT BROKEN. THE EMERGENCY RELEASE ON THE DELIVERY SYSTEM WAS NOT IMPLEMENTED. THE WIRE THAT HOLDS THE CAPSULE WAS COMPLETELY OFF AND THE FOAM GASKET WAS IN GOOD CONDITION. THE DELIVERY SYSTEM DID NOT HAVE ANY VISIBLE DAMAGE. AS THE PRODUCT WAS RECEIVED, THE DEVICE FUNCTIONED PER SPECIFICATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED BRAVO CAPSULE FAILED TO ATTACH. THERE WAS NO HARM TO THE PT OR USER.

    Description of Event or Problem · 1

    A REPEAT PROCEDURE WAS NECESSARY DUE TO THE ALLEGED DEVICE MALFUNCTION. INTERVENTION WAS NOT REQUIRED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR PROCEDURE ITSELF THAT MAY HAVE LED TO THIS EVENT. AN ENDOSCOPY WAS PERFORMED PRIOR TO THE PROCEDURE AND THE ESOPHAGUS APPEARED TO BE NORMAL. THE DEVICE OPERATOR HAS BEEN PERFORMING THIS PROCEDURE FOR FIVE YEARS. LUBRICANT WAS USED TO FACILITATE CAPSULE PLACEMENT AND THE REPORTER CONFIRMED THAT NO LUBRICANT WENT INTO THE CAPSULE CHAMBER. NO KNOWN ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525548 BRAVO PH CAPSULE DELIVERY DEVICE BRAVO FFT GIVEN IMAGING LTD. FGS-0313 27133Q

    Patients

    Seq Age Sex Outcome Treatment
    1