BEUDAMED
    FDA Adverse Event Other Summary report: N

    FUJINON

    MDR report key: 1993335 · Received February 4, 2011

    Report

    Report Number
    2431293-2011-00002
    Event Type
    Other
    Date Received
    February 4, 2011
    Date of Event
    January 4, 2011
    Report Date
    February 4, 2011
    Manufacturer
    FUJIFILM OPTICAL CORP
    Product Code
    FED
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER NOTIFIED FUJINON OF AN INCIDENT INVOLVING A FUJINON (B)(4) OVERTUBE. DURING A PROCEDURE TWO NOTICEABLE PIECES OF THE BLACK SILICONE RING USED TO SECURE A BALLOON ON THE END OF THE OVERTUBE BROKE AWAY/PEELED OFF AND NEEDED TO BE EXTRACTED THROUGH THE BIOPSY CHANNEL WITH FORCEPS. THE PHYSICIAN MUST HAVE VIEWED THE LOOSE PIECES ON THE MONITOR BECAUSE HE DID NOT HAVE TO REMOVE THE SCOPE IN ORDER TO EXTRACT THE DEBRIS. HE COMPLETED THE PROCEDURE SUCCESSFULLY AND DISCARDED THE OVERTUBE AFTER USE. THE PHYSICIAN FELT CONFIDENT THAT THE DEBRIS WAS NOT PLACING THE PT AT RISK AND THAT HE WAS ABLE TO REMOVE IT. HE DID NOT FEEL THAT ANY FURTHER PROCEDURES WERE NECESSARY TO SEARCH FOR OR RETRIEVE ANY ADDITIONAL MATTER. FUJINON EXAMINED ANOTHER OVERTUBE FROM THE SAME LOT; NO ABNORMALITIES WERE DETECTED. THE MFG FACILITY, FUJIFILM, WAS CONTACTED AND INFORMED FUJINON THAT THEY REVIEWED THE MFG RECORDS AND NO DEFECTIVE UNITS WERE OBSERVED. EACH OVERTUBE IS INSPECTED FOR ANY LOOSE PARTS, ABSENCE OF ROUGH SURFACES, SHARP EDGES, PROTECTION/PROTRUSIONS, DAMAGE, CONTAMINATION, STRAIN/STRESS AND DISCOLORATION. ADDITIONALLY, BASED ON BIOCOMPATIBILITY DATA FOR SILICONE, THIS INCIDENT POSES NO ADVERSE EFFECT ON THE PT. THE CAUSE FOR THIS INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    PIECES OF THE BLACK SILICONE RING USED TO SECURE A BALLOON ON AN OVERTUBE ((B)(4)) BROKE AWAY DURING A PROCEDURE AND NEEDED TO BE EXTRACTED FROM THE PT'S SMALL INTESTINE. DOCTOR REMOVED TWO NOTICEABLE PIECES THROUGH THE BIOPSY CHANNEL AND SUCCESSFULLY COMPLETED THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUJINON OVERTUBE FED FUJIFILM OPTICAL CORP TS-13140 100929

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention