BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 1011612 · Received March 12, 2008

    Report

    Report Number
    8010047-2008-00040
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 13, 2008
    Report Date
    February 14, 2008
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS RETUNED TO OLYMPUS FOR INVESTIGATION AFTER HAVING REPORTEDLY SENT TO A THIRD PARTY SVC PROVIDER. THE INVESTIGATION CONFIRMED THAT USER'S REPORT OF ELEVATOR NOT WORKING PROPERLY. THE DEVICE WAS TESTED WITH A BIOPSY FORCEP AND THE ELEVATOR RAISER WAS UNABLE TO HOLD THE FORCEPS IN PLACE. IN ADDITION, LOW ELEVATION WAS OBSERVED ON THE ELEVATOR RAISER DUE TO A SHORT ELEVATOR WIRE. THE DISTAL TIP COVER AND BENDING SECTION COVER AND GLUE WERE FOUND TO BE NON-OLYMPUS PARTS. THERE WERE BROKEN/FRAYED WIRES NOTED UPON REMOVAL OF THE BENDING SECTION COVER, LIKELY DUE TO EXTENSIVE USE. THE CAUSE OF THE USER'S EXPERIENCE CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, SVC PROVIDED BY AN UNK THIRD-PARTY SVC AND PARTS CANNOT BE RULED OUT AS CONTRIBUTING FACTORS. THIS REPORT IS BEING FILED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIO PANCREATOGRAPHY (ERCP) WITH A STENT PLACEMENT, THE ELEVATOR RAISER OF THE ENDOSCOPE DID NOT HOLD THE STENT IN THE PROPER POSITION WHEN STRESS WAS APPLIED. THE GI LAB COORD AT THE FACILITY REPORTED THAT THEY TRIED USING THREE DIFFERENT TYPES OF NON-OLYMPUS STENTS, BUT STILL THE ELEVATOR RAISER DID NOT HOLD THE STENTS IN POSITION. THE PHYSICIAN ELECTED TO WITHDRAW THE ENDOSCOPE FROM THE PT, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT, BUT SIMILAR DEVICE. THE LAB COORD REPORTED THE PROCEDURE WAS PROLONGED BY APPROX 90 MINS. THERE WERE NO COMPLICATION AND NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORPORATION TJF-160VF

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK