BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS

    MDR report key: 1060131 · Received June 3, 2008

    Report

    Report Number
    8010047-2008-00097
    Event Type
    Injury
    Date Received
    June 3, 2008
    Date of Event
    December 7, 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 USER'S EXPERIENCE CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. OLYMPUS IS CURRENTLY WORKING WITH THE USER FACILITY TO OBTAIN ADDITIONAL DETAILED INFO. IF SIGNIFICANT ADDITIONAL INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL FOLLOW. THIS REPORT IS BEING FILED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. REFERENCE MFR REPORT NUMBERS 8010047-2008-00098, 8010047-2008-00099, AND 8010047-2008-00100 FOR THE OTHER THREE RELEVANT REPORTED EVENTS. NOTE, WHILE THE USER FACILITY REPORT INDICATES THAT THIS IS THE THIRD PT IN THE GROUP, BASED UPON THE EVENT DATE, IT APPEARS TO BE THE SECOND PT.

    Description of Event or Problem · 1

    OLYMPUS RECEIVED 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 THIRD 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 DEVICE WERE UTILIZED DURING THESE PROCEDURES. THIS UNUSUAL CLUSTER OF INCIDENTS HAS NEVER OCCURRED BEFORE, AND SO THEY ARE BEING INVESTIGATED. THIS CHILD HAD THREE POLYPS THAT WERE HARDER TO REMOVE, HOWEVER LESSER JOULES SETTING WAS USED. PRESENTED THREE DAYS AFTER PROCEDURE WITH NO SUBSEQUENT SURGERY REQUIRED. PT RECOVERED WELL. CAT SCAN OF THE ABDOMEN AND PELIVS REVEALED FOCAL THICKENING OF THE COLON NEAR THE HEPATIC FLEXURE WITH SURROUNDING INFLAMMATORY CHANGES CONSISTENT WITH CONTAINED COLONIC PERFORATION." UPON FURTHER INVESTIGATION, THE USER FACILITY REPORTED THAT THE PT HAD EXPERIENCED RECTAL BLEEDING DUE TO A COLON POLYP. 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. A TEMPORARY COLOSTOMY WAS PERFORMED 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 PEDIATRIC COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORPORATION PCF-140L NA

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization| R OLYMPUS EVIS VIDEO SYSTEM CENTER| CONMED ELECTROSURGERY ELECTRICAL SURGICAL UNIT| DEVICE MODEL SABRE 2400| ON SETTINGS 20/20| BOSTON SCIENTIFIC CORP SENSATION POLYPECTOMY SNARE| DEVICE MODEL CV-140, 7771378| OLYMPUS EVIS EXERA II XENON LIGHT SOURCE| DEVICE MODEL UNK, 770639| DELL FLAT SCREEN TV| DEVICE MODEL 6265, LOT NUMBER UNK| OLYMPUS KEYBOARD| OLYMPUS FLAT SCREEN TV, DEVICE MODEL OEV191