BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVERTUBE

    MDR report key: 2517862 · Received March 27, 2012

    Report

    Report Number
    2431293-2012-00002
    Event Type
    Malfunction
    Date Received
    March 27, 2012
    Date of Event
    January 3, 2012
    Report Date
    March 26, 2012
    Manufacturer
    FUJIFILM OPTICS CO LTD, SANO FACTORY
    Product Code
    FED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FUJIFILM RECEIVED THE DAMAGED OVERTUBE FROM THE CUSTOMER IN (B)(4) 2012, AND PERFORMED A VISUAL EXAMINATION. THE BALLOON WAS DAMAGED AND BROWN RESIDUE WAS PRESENT. NO FURTHER MECHANICAL TESTS WERE PERFORMED DUE TO THE BALLOON BEING RUPTURED. BASED ON THE INFO WE HAVE, A ROOT CAUSE COULD NOT BE ESTABLISHED. FUJIFILM RETRIEVED THE PUMP (PB-20) USED DURING THE PROCEDURE AND INSPECTED THE DEVICE ON (B)(4) 2012. THE PUMP IS OPERATING NORMALLY. FUJIFILM ARRANGED TO HAVE AN EMPLOYEE (CLINICAL SPECIALIST) VISIT THE CUSTOMER SITE ON (B)(4) 2012, TO OBSERVE CASES, SUGGEST CORRECTIVE MEASURES AND IN-SERVICE THE STAFF IF NECESSARY. THE CLINICAL SPECIALIST DISCOVERED THE CUSTOMER WAS NOT USING FUJIFILM STANDARD PUMP FILTERS, WHICH CAN CLOG AND HINDER AIR FLOW IN AND OUT OF THE BALLOON. A SUGGESTION WAS MADE TO THE CUSTOMER TO PURCHASE CURRENT FILTERS FROM FUJIFILM. HE ALSO SUGGESTED DATING AND TRACKING THE USER OF THE FILTERS AFTER INSTALLATION, AND REPLACING THEM ROUTINELY ACCORDING TO CASE LOAD. THE PB-20 PUMP OPERATION MANUAL RECOMMENDS CHANGING THE FILTERS ONCE EVERY MONTH OR ONCE EVERY 10 CASES. CUSTOMER WAS INFORMED OF THE PICTURE-IN-PICTURE FEATURE FOUND ON THE PB-20 PUMP, WHICH CAN DISPLAY BALLOON STATUS ON THE MONITOR THROUGHOUT THE PROCEDURE. THIS FEATURE MAY HAVE BEEN HELPFUL IN ALERTING THE STAFF OF A RUPTURED BALLOON IN THE REPORTED CASE.

    Description of Event or Problem · 1

    ACCORDING TO THE MEDWATCH RECEIVED BY FUJIFILM FROM FDA ON (B)(6) 2012, THE USER STATED "DURING WITHDRAWAL OF THE SCOPE, IT WAS DISCOVERED THE BALLOON RUPTURED AT SOME POINT. THERE WAS NO HARM TO THE PT, BUT COULD HAVE RESULTED IN ASPIRATION. THE BALLOON TESTED AS NORMAL PRE-PROCEDURE. THE RESIDUAL BALLOON PIECE WAS SUCCESSFULLY RETRIEVED VIA BIOPSY FORCEPS." 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.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other