BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS

    MDR report key: 1060206 · Received June 3, 2008

    Report

    Report Number
    8010047-2008-00100
    Event Type
    Injury
    Date Received
    June 3, 2008
    Date of Event
    October 19, 2007
    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 PT'S OUTCOME CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. 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 NUMBERS 8010047-2008-00097, 8010047-2008-00098, AND 8010047-2008-00099 FOR THE OTHER THREE RELEVANT REPORTED EVENTS. NOTE, WHILE THE USER FACILITY REPORT INDICATES THE DATE OF THE EVENT AS 2007, UPON FURTHER INVESTIGATION, THE USER FACILITY REPORTED THAT THE DATE OF THE EVENT OCCURRED 9 DAYS OF THE ORIGINAL EVENT DATE.

    Description of Event or Problem · 1

    OLYMPUS RECEIVED A COPY OF A MEDWATCH FDA 3500A FORM, REFERENCING AN OLYMPUS COLONOSCOPE BEING USED AS A CONCOMITANT DEVICE TO THE REPORTED EVENT. THE USER FACILITY STATED IN THE EVENT DESCRIPTION, "THIS IS THE FIRST PT OF FOUR PTS WHO EXPERIENCED BOWEL PERFORATIONS FOLLOWING COLONOSCOPY PROCEDURES PERFORMED IN THE SURGERY CENTER DURING A FOUR MONTH 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." UPON FURTHER INVESTIGATION, THE USER FACILITY REPORTED THAT THE PT HAD BEEN EXPERIENCING RECTAL BLEEDING AND ABDOMINAL PAIN. THE USER FACILITY PERFORMED A THERAPEUTIC COLONOSCOPY. FOLLOWING THE PROCEDURE, THE PT WAS ADMITTED TO THE HOSP TWO DAYS LATER, AND WAS DIAGNOSED WITH A BOWEL PERFORATION. SURGICAL INTERVENTION WAS PROVIDED TO CORRECT THE PERFORATION. THE PT WAS REPORTEDLY HOSPITALIZED FOR FIVE DAYS AND HAS COMPLETELY RECOVERED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORPORATION CF-Q160AL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization| R OLYMPUS KEYBOARD| DEVICE MODEL UNK| OLYMPUS EVIS EXERA II XENON LIGHT SOURCE,| OLYMPUS EVIS VIDEO SYS CTR, DEVICE MODEL CV-140,| OLYMPUS FLAT SCREEN TV, DEVICE MODEL OEV191,| CONMED ELECTROSURGERY ELECTRICAL SURGICAL UNIT,| DEVICE MODEL SABRE 2400 ON| DEVICE MODEL 6265, LOT #UNK.| SETTINGS 20/20.| BOSTON SCIENTIFIC CORP SENSATION POLYPECTOMY SNARE| DELL FLAT SCREEN TV