BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVERTUBE

    MDR report key: 2440574 · Received January 20, 2012

    Report

    Report Number
    2431293-2012-00001
    Event Type
    Malfunction
    Date Received
    January 20, 2012
    Date of Event
    October 26, 2011
    Report Date
    January 20, 2012
    Manufacturer
    FUJIFILM OPTICS INC., LTD.
    Product Code
    FED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIVING A COPY OF THE MEDWATCH REPORT FROM FDA, FUJIFILM (FF) CONTACTED THE CUSTOMER (B)(6) TO RETRIEVE THE OVERTUBE AND BP-20 PUMP REQUIRED TO INFLATE AND DEFLATE THE OVERTUBE DURING CLINICAL USE. FF ALSO CONFIRMED THAT NO PT INJURY OCCURRED AS A RESULT OF THIS INCIDENT. ACCORDING TO INTERNAL RECORDS, THIS CUSTOMER ONLY HAS ONE BP-20 PUMP WHICH HAD BEEN IN USE SINCE THE DATE OF INCIDENT ((B)(6) 2011). THE PUMP WAS THOROUGHLY EXAMINED BY FF IN (B)(6) ON (B)(6) 2012 AND NO ABNORMALITIES WERE FOUND. THE CUSTOMER ALSO RETURNED TWO OVERTUBES TO FF, ONE FROM LOT NO: 110525 AND ANOTHER FROM AN UNK LOT. NO EVIDENCE OF CLOGGING, KINKING OR OTHER ABNORMALITY THAT COULD HAVE CAUSED THE REPORTED INCIDENT. THE BALLOON INFLATED AND DEFLATED WITHOUT INCIDENT. THE SECOND OVERTUBE HAD A DAMAGED BALLOON AND BROWN RESIDUE WAS PRESENT. NO ADD'L DETAILS COULD BE OBTAINED REGARDING TO THE USE OF THIS OVERTUBE. HOWEVER, THIS OVERTUBE COULD NOT HAVE BEEN THE ONE INVOLVED IN THE INCIDENT SINCE THE CUSTOMER STATED IN THEIR MEDWATCH REPORT THAT THE BALLOON COULD BE DEFLATED WITH A SYRINGE. FF WAS UNABLE TO DUPLICATE THE INCIDENT, NOR WERE ANY ABNORMALITIES DETECTED. THERE HAVE BEEN NO OTHER COMPLAINTS RECEIVED ON THE SUBJECT LOT OF OVERTUBES. FF COULD NOT OBTAIN ADD'L INFO REGARDING THE CLINICAL PROCEDURE FROM THE USER FACILITY AS TWO MONTHS HAD PASSED SINCE THE DATE OF THE INCIDENT BY THE TIME FF WAS MADE AWARE. AFTER THOROUGH EXAMINATION OF THE EQUIPMENT WITH THE INCIDENT, THE PROBABLE CAUSE FOR THIS INCIDENT MAY BE ATTRIBUTED TO USER ERROR. IT IS POSSIBLE THAT THE USER MAY HAVE INADVERTENTLY INTRODUCED WATER INTO THE AIR FEED TUBE, IN DOING SO, THIS COULD CAUSE THE BALLOON NOT TO DEFLATE AS EXPECTED OR A MOMENTARY KINK IN THE AIR FEED LINE MAY HAVE OCCURRED WHILE THE USER WAS MANIPULATING THE ENDOSCOPE AND OVERTUBE DURING THE PT PROCEDURE THEREFORE, POSSIBLY CAUSING THE BALLOON NOT THE DEFLATE AS EXPECTED.

    Description of Event or Problem · 1

    ACCORDING TO THE MEDWATCH RECEIVED BY FUJIFILM FROM FDA ON (B)(6) 2011, THE USER STATED "THE BALLOON WOULD NOT DEFLATE WHEN BEING USED DURING THE PROCEDURE. THE SYRINGE WAS CONNECTED TO THE OVERTUBE AND THE BALLOON WAS ABLE TO BE DEFLATED. WHAT WAS THE ORIGINAL INTENDED PROCEDURE" BALLOON ASSISTED ENDOSCOPY DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO. DEVICE USAGE PROBLEM: DEVICE FAILED (EG BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVERTUBE OVERTUBE FED FUJIFILM OPTICS INC., LTD. TS-13140 110525

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other