BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS EVIS EXERA GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 1954604 · Received December 7, 2010

    Report

    Report Number
    8010047-2010-00242
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    November 6, 2010
    Report Date
    November 8, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO GATHER ADDITIONAL INFORMATION REGARDING THIS REPORT. THE USER FACILITY REPORTED THAT THE PT WAS ADMITTED WITH A SEVERE GI BLEED, AND THAT MULTIPLE CLIPS WERE DEPLOYED WHILE THE USERS WERE ATTEMPTED TO STAUNCH THE BLEEDING. THE PROCEDURE WAS SAID TO HAVE BEEN DELAYED FOR AN UNSPECIFIED PERIOD WHEN THE USERS ATTEMPTED TO OBTAIN THE SECOND GASTROSCOPE. THERE WAS NO INFORMATION PROVIDED AS TO HOW LONG THE PROCEDURE WAS DELAYED. THE DEVICE REFERENCED WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION FOUND SCRAPE MARKS INSIDE THE SUCTION CYLINDER PORT. ADDITIONALLY, THERE WERE MINOR AMOUNTS OF DEBRIS AND RESIDUE NOTED INSIDE THE CHANNEL MOUNT, SUCTION CYLINDER AND AT THE DISTAL END OF THE INSTRUMENT CHANNEL. THE GASTROSCOPE WAS TESTED WITH THE RETURNED SUCTION VALVES AND NO DIFFICULTY WAS DETECTED. THE DEVICE WAS DETERMINED TO BE LEAKING AND THE BENDING SECTION WAS TORN. THERE WAS A CUT IN THE NUMBER ONE BUTTON. THE DEVICE WAS REFURBISHED. PLEASE REFERENCE MEDWATCH #3600510000-2010-8023 WHICH PROVIDED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. PLEASE ALSO REFERENCE MFR REPORT NUMBER 8010047-2010-00243. BASED UPON ALL AVAILABLE INFORMATION, IT APPEARS THAT THE SUCTION WAS REDUCED BY THE PRESENCE OF COPIOUS AMOUNTS OF BLOOD AND/OR ASPIRATION OF BIOMATERIAL. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE SUBJECT DEVICE WAS USED DURING A THERAPEUTIC ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE ON A PT EXPERIENCING A SEVERE GASTROINTESTINAL (GI) BLEED. DURING THE PROCEDURE, THE SUCTION VALVE OF THE GASTROSCOPE REPORTEDLY BECAME STUCK IN THE DEPRESSED POSITION AND A DIFFERENT BUT SIMILAR GASTROSCOPE WAS EMPLOYED TO ATTEMPT TO COMPLETE THE PROCEDURE. HOWEVER, THE SUCTION VALVE OF THE SECOND GASTROSCOPE REPORTEDLY BECAME STUCK AS WELL. THE PT WAS TRANSFERRED TO THE OPERATING ROOM AND OPEN SURGERY WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED REGARDING THE STATUS OF THE PT FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GASTROSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORPORATION GIF-2T160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CATALOG # 2261| MODEL NUMBER GIF-2T160, SERIAL # (B)(4)| OLYMPUS EVIS EXERA GASTROINTESTIAL VIDEOSCOPE| BOSTON SCIENTIFIC RESOLUTION CLIPS