BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS EVIS EXERA GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 3177180 · Received June 12, 2013

    Report

    Report Number
    8010047-2013-00180
    Event Type
    Injury
    Date Received
    June 12, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 13, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    GCK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORT AND WAS INFORMED THAT THE IMAGE ON THE SUBJECT DEVICE FROZE MULTIPLE TIMES BEFORE THE PROCEDURE STARTED. THE USER ELECTED TO USE THE SUBJECT DEVICE FOR A DIAGNOSTIC ESOPHAGOGASTRODUODENOSCOPY (EGD). IN THE BEGINNING OF THE EGD, WHEN THE USER WAS ADVANCING THE SUBJECT DEVICE DOWN THE ESOPHAGUS, IT WAS SAID THAT THE IMAGE FROZE 2-3 TIMES. THE USER REPORTEDLY FELT RESISTANCE WHEN THE SUBJECT DEVICE WAS BEING REMOVED FROM THE PATIENT. THE IMAGE WAS SAID TO HAVE FROZEN AGAIN. BLEEDING WAS NOTED AFTERWARDS. A DIFFERENT BUT SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE BLEEDING WAS SAID TO HAVE STOPPED ITSELF AND A TEAR ON THE ESOPHAGUS WAS NOTED AT THAT POINT. THE PATIENT WAS SAID TO BE ADMITTED OVERNIGHT FOR OBSERVATION AND THE PATIENT WAS PROVIDED PROTONICS. THE PATIENT WAS SAID TO BE DISCHARGED THE FOLLOWING DAY AND WAS REPORTEDLY DOING FINE. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION CONFIRMED THE IMAGE DIFFICULTY. ALSO, SWITCH BUTTON #1 WAS MISALIGNED, LOCKING UP, AND SHORTING OUT INTERMITTENTLY, WHICH LIKELY CAUSED THE USER'S EXPERIENCE. IN ADDITION, THE INSERTION TUBE WAS DENTED AT THE 39 CM AND 44 CM MARK. A REVIEW OF THE INSTRUMENT HISTORY SHOW THAT THE USER FACILITY PURCHASED THE DEVICE ON (B)(6) 2009 BUT HAS NO OTHER SERVICE EVENTS. THE EXACT CAUSE OF THE PATIENT OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, THE PATIENT'S PRE-EXISTING CONDITION COULD NOT BE RULED OUT AS A CONTRIBUTORY FACTOR.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE IMAGE ON THE SUBJECT DEVICE WAS FREEZING INTERMITTENTLY. BLEEDING WAS SAID TO HAVE BEEN NOTED ON THE PATIENT'S ESOPHAGUS. PATIENT WAS SAID TO HAVE BEEN ADMITTED TO THE ICU DUE TO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266813 OLYMPUS EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE GCK OLYMPUS MEDICAL SYSTEM CORPORATION GIF-160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| O| R