BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS

    MDR report key: 1060167 · Received June 3, 2008

    Report

    Report Number
    8010047-2008-00099
    Event Type
    Injury
    Date Received
    June 3, 2008
    Date of Event
    February 19, 2008
    Report Date
    May 5, 2008
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES UTILIZED IN THIS REPORTED EVENT WERE NOT RETURNED TO OLYMPUS FOR INVESTIGATION. THE CAUSE OF THE USER'S EXPERIENCE CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. THE OLYMPUS IS CURRENTLY WORKING WITH THE USER FACILITY TO OBTAIN ADD'L DETAILED INFO. IF SIGNIFICANT ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL FOLLOW. THIS REPORT IS BEING FILED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. ADD'L COMMENTS: REFERENCE MFR REPORT #S: 8010047-2008-00097, 00098, AND 00100 FOR THE OTHER THREE RELEVANT REPORTED EVENTS.

    Description of Event or Problem · 1

    OLYMPUS REC'D A COPY OF A MEDWATCH FDA 3500A FORM, REFERENCING AN OLYMPUS COLONOSCOPE AS A CONCOMITANT DEVICE TO THE REPORTED EVENT. THE USER FACILITY STATED IN THE EVENT DESCRIPTION "THIS IS THE FOURTH PT WHO EXPERIENCED BOWEL PERFORATIONS FOLLOWING COLONOSCOPY PROCEDURES PERFORMED IN THE SURGERY CENTER DURING A FOUR MO SPAN. SIMILAR ESU AND CABLE DEVICES WERE UTILIZED DURING THESE PROCEDURES. THIS UNUSUAL CLUSTER OF INCIDENTS HAS NEVER OCCURRED BEFORE, AND SO THEY ARE BEING INVESTIGATED. THIS PT EXPERIENCED A PERFORATED BOWEL WITH PERITONITIS AND WAS RETURNED TO SURGERY FOR BOWEL REPAIR." MULTIPLE ATTEMPTS WERE MADE BY PHONE AND IN WRITING TO OBTAIN ADD'L DETAILED INFO FROM THE USER FACILITY REGARDING THIS EVENT, HOWEVER NO ADD'L DETAILED INFO HAS BEEN REC'D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS PEDIATRIC COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORPORATION PCF-140L NA

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization| R DEVICE MODEL 6265, LOT # UNK| OLYMPUS EVIS UNIVERSAL LIGHT SOURCE, CLV-U40| CONMED ELECTROSURGERY ELECTRICAL SURGICAL UNIT| OLYMPUS KEYBOARD| OLYMPUS COLOR PRINTER, DEVICE MODEL OEP| OLYMPUS EVIS VIDEO SYS CENTER, DEVICE MODEL CV-140| OLYMPUS LCD MONITOR,| BOSTON SCIENTIFIC CORP SENSATION SHORT THROW SNARE| ON SETTINGS 15-20/15-20.| DEVICE MODEL SABRE 2400