BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS EVIS EXERA COLONVIDEOSCOPE

    MDR report key: 1872081 · Received October 12, 2010

    Report

    Report Number
    8010047-2010-00210
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 27, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    FTJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFO REGARDING THE REPORTED EVENT, AND WAS INFORMED THAT THE DEVICE WAS BEING USED IN A DIAGNOSTIC COLONOSCOPY. THE PERFORATION WAS OBSERVED AT THE SIGMOID COLON, AND UPON DISCOVERY, THE COLONOSCOPE WAS IMMEDIATELY REMOVED FROM THE PT. PERITONEAL FAT WAS SAID TO HAVE BEEN NOTED ON THE DEVICE AFTER COLONOSCOPE WAS REMOVED FROM THE PT. THE USER FACILITY ALSO REPORTED TO HAVE PERFORMED A VISUAL AND MECHANICAL INSPECTION OF THE DEVICE AND DID NOT OBSERVE ANY INDICATIONS OF DAMAGE THAT COULD CREATE POOR CLINICAL OUTCOMES. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVAL, THE EVAL NOTED THE PRESENCE OF SMALL DENTS AND SCRATCHES ON THE DISTAL END COVER, INSERTION TUBE, OBJECTIVE LENS, LIGHT GUIDE TUBE, AND MINOR CRACKS IN THE GLUE BONDS ON THE BENDING SECTION COVER. THE OBJECTIVE LENS HAD SMALL CHIPS AROUND THE EDGE. THE NICKS AND SCRATCHES WERE CAREFULLY INSPECTED, AND DETERMINED NOT TO BE SHARP. THE DEVICE WAS SERVICED. THE EXACT CAUSE OF THE PT OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. THIS IS REPORT ONE OF TWO, PLEASE SEE ALSO MFR#8010047-2010-22011 FOR A RELATED REPORT.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE SUBJECT COLONVIDEOSCOPE WAS USED IN A COLONOSCOPY IN WHICH THE PT REPORTEDLY SUSTAINED A PERFORATION. THE PT WAS TRANSPORTED TO ANOTHER FACILITY FOR SURGICAL CORRECTION. THE PT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA COLONVIDEOSCOPE COLONOSCOPE FTJ OLYMPUS MEDICAL SYSTEM CORPORATION CF-Q160AL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR