BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 1080089 · Received July 17, 2008

    Report

    Report Number
    8010047-2008-00126
    Event Type
    Malfunction
    Date Received
    July 17, 2008
    Date of Event
    June 16, 2008
    Report Date
    June 17, 2008
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS AMERICA FOR INVESTIGATION. THE CAUSE OF THE USER'S EXPERIENCE CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF SIGNIFICANT ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE PROVIDED. THIS REPORT IS BEING FILED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A THERAPEUTIC COLONOSCOPY, THE PHYSICIAN ELECTED TO CAUTERIZE THE POLYP WITH THE ELECTROSURGICAL SNARE DUE TO THE AWKWARD POSITION OF THE POLYP INSIDE THE BOWEL. AS THE PHYSICIAN ACTIVATED THE ELECTRICAL SURGICAL UNIT, THE SNARE REPORTEDLY SPARKED AND SMOKED. SUBSEQUENTLY, THE TIP OF THE SNARE WAS REPORTED TO HAVE FELL INSIDE THE PT'S COLON. THE PHYSICIAN UTILIZED BIOPSY FORCEPS TO REMOVE THE SNARE TIP WITH NO COMPLICATIONS. THE USER FACILITY REPORTEDLY COMPLETED THE PROCEDURE WITH A DIFFERENT, BUT SIMILAR SNARE. THE USER FACILITY STATED NO HARM WAS DONE TO THE PT. MULTIPLE ATTEMPTS WERE MADE BY PHONE AND IN WRITING TO OBTAIN ADD'L DETAILED INFO FROM THE USER FACILITY, HOWEVER, ONLY LIMITED ADD'L INFO WAS REC'D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS DISPOSABLE POLYPECTOMY SNARE FDI OLYMPUS MEDICAL SYSTEMS CORPORATION SD-210U-15 82K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK