BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUJINON

    MDR report key: 2773963 · Received September 26, 2012

    Report

    Report Number
    2431293-2012-00004
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    May 29, 2012
    Report Date
    August 4, 2012
    Manufacturer
    FUJIFILM OPTICS, CO. LTD. SANO FACTORY
    Product Code
    FED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    FUJIFILM (FF) CONTACTED (B)(6) TO OBTAIN ADDITIONAL INFO AND LEARNED THAT THERE WAS NO PT INJURY AS A RESULT OF THIS INCIDENT. THE CUSTOMER HAD DISCARDED THE OVERTUBE IN QUESTION AND THEREFORE, NO ADDITIONAL EVAL OF THE DEVICE COULD BE PERFORMED. A FUJIFILM FIELD SERVICE ENGINEER VISITED THE CUSTOMER AND EXAMINED THE PB-20 PUMP USED TO INFLATE AND DEFLATE THE OVERTUBE BALLOON AND FOUND THAT IT WAS FUNCTIONING PROPERLY. HE TESTED THE PUMP SEVERAL TIMES WITH AN EXPIRED OVERTUBE TO RECREATE THE INCIDENT, HOWEVER, HE WAS UNSUCCESSFUL IN HIS ATTEMPTS AND THEREFORE, COULD NOT SUBSTANTIATE THE COMPLAINT. THE CUSTOMER STATED IN THEIR MEDWATCH REPORT THAT THE BALLOON FAILED TO "COMPLETELY" DEFLATE. IN THE ABSENCE OF THE SUBJECT OVERTUBE, FF COULD NOT DETERMINE TO WHAT DEGREE THE BALLOON FAILED TO DEFLATE. FF HAD INFORMED THE CUSTOMER PREVIOUSLY TO CHANGE THE FILTERS ON THEIR PB-20 MORE FREQUENTLY. THE CUSTOMER HAS SINCE IMPLEMENTED THIS RECOMMENDATION, HOWEVER, FF IS UNABLE TO DETERMINE IF THE INCIDENT OCCURRED BEFORE OR AFTER (B)(6) HAD UPDATED THEIR INTERNAL PROCEDURE. TO DATE, NO ADDITIONAL INCIDENCES INVOLVING OVERTUBES HAVE BEEN REPORTED BY THE (B)(6). THEY HAVE BEEN INFORMED TO CONTACT FF'S CLINICAL SPECIALIST IMMEDIATELY AND TO RETAIN THE USED DEVICE (S) IF AN EVENT OCCURS. IN ADDITION, NO OTHER CUSTOMER HAVE REPORTED INCIDENCES OF THIS NATURE.

    Description of Event or Problem · 1

    FUJIFILM RECEIVED A COPY OF A MEDWATCH FROM (B)(6) SENT BY THE (B)(6), STATING THAT "THE OVERTUBE BALLOON FAILED TO COMPLETELY DEFLATE BEFORE IT WAS REMOVED FROM THE PT. EQUIPMENT REGISTERED BALLOON WAS DEFLATED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUJINON TS-13140 OVERTUBE (FOR EN-450T5) FED FUJIFILM OPTICS, CO. LTD. SANO FACTORY TS-13140 1112C9

    Patients

    Seq Age Sex Outcome Treatment
    1 Other