BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS EVIS EXERA DUODENOVIDEOSCOPE

    MDR report key: 2233020 · Received July 19, 2011

    Report

    Report Number
    8010047-2011-00163
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 20, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    FDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFO REGARDING THE REPORT AND WAS INFORMED THAT TOWARD THE END OF THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WHEN THE PHYSICIAN WAS REMOVING THE CANNULATING DEVICES (HYDROTOME/GUIDE WIRE) FROM THE DUODENOVIDEOSCOPE, THE GUIDE WIRE SLIPPED OUT OF THE V-SHAPE OF THE FORCEPS ELEVATOR AND THE GUIDE WIRE BECAME CAUGHT IN THE ELEVATOR AND SHREDDING OF THE HYDROTOME WAS OBSERVED. THE NURSE REPORTED THAT THERE WAS ONE SMALL PARTICLE THAT HAD FALLEN INSIDE THE PT IN THE DUODENAL AND PAPILLA REGION. THE PARTICLE WAS SUCTIONED WITH THE DUODENOVIDEOSCOPE. THE HYDROTOME AND GUIDE WIRE WERE SIMULTANEOUSLY WITHDRAWN FROM THE PT. THERE WAS NO PT INJURY REPORTED. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL DID NOT FIND ANY PROBLEM WITH THE DEVICE, AS THERE WAS NO EVIDENCE OF RESTRICTIONS, CATCHING OR BLOCKAGE WITH THE ELEVATOR FORCEPS RAISER. THE INSTRUMENT CHANNEL OF THE DUODENOVIDEOSCOPE WAS EXAMINED USING A BORESCOPE AND NO EVIDENCE OF KINKS, DENTS OR FOREIGN OBJECTS WERE FOUND. THE ELEVATION OF THE FORCEPS RAISER AND MOVEMENT OF THE FORCEPS RAISER ARE FOUND TO BE WITHIN THE STANDARD. THE DEVICE WAS INSPECTED AND WAS RETURNED TO THE USER FACILITY. THE EXACT CAUSE OF THE USER'S EXPERIENCE COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, USER TECHNIQUE COULD NOT BE RULED OUT AS A CONTRIBUTORY FACTOR TO THE REPORTED EVENT. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE PHYSICIAN WAS TRYING TO PULL OUT THE CANNULA AND THE GUIDE WIRE WAS CAUGHT AT THE ELEVATOR FORCEPS AND THE GUIDE-WIRE BECAME SHREDDED INSIDE THE PT. THE PHYSICIAN REPORTEDLY SUCTIONED ALL PIECES. THERE WAS NO REPORT OF ANY PT HARM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 BOSTON SCIENTIFIC AUTOTOME RX39 WITH JAGWIRE .25| THE PROCEDURE.| .35 GUIDEWIRE WERE SAID TO HAVE BEEN USED DURING| AND HYDROTOME 44 THAT COMES WITH