BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS EVIS EXERA II GI VIDEOSCOPE

    MDR report key: 2860297 · Received November 30, 2012

    Report

    Report Number
    8010047-2012-00448
    Event Type
    Other
    Date Received
    November 30, 2012
    Date of Event
    September 11, 2012
    Report Date
    November 1, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFO. PER THE USER FACILITY, THE PT HAD TO BE TRANSFERRED TO ANOTHER FACILITY BUT NO SURGICAL INTERVENTION WAS NECESSARY. PER THE FACILITY, THIS WAS AN UNANTICIPATED COMPLICATION OF THE PROCEDURE. THE PT IS DOING WELL. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVAL AS THE USER FACILITY DID NOT ATTRIBUTE THE INCIDENT TO DEVICE MALFUNCTION OR DEFECT. THE SCOPE IS FUNCTIONING APPROPRIATELY. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ACCESS OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS RECEIVED A MAUDE EVENT REPORT STATING THAT A PT WAS ADMITTED TO ENDOSCOPY WITH PRE-OPERATIVE DIAGNOSIS OF GASTROPHAGEAL REFLUX DISEASE. ENDOSCOPY WAS DONE WITH OLYMPUS GASTROINTESTINAL VIDEOSCOPE AND DILATATION WITH A CONMED ELIMINATOR 20MM BALLOON DILATOR. THE USER PASSED THE VIDEOSCOPE INTO THE DUODENUM, PAST THE DUODENAL SWEEP, AND INTO THE DISTAL DUODENUM. ALL HAD NORMAL APPEARANCE TO IT. THEN THE PHYSICIAN PULLED BACK SLOWLY. HE GOT INTO THE LOWER ESOPHAGUS AND DID SOME BIOPSIES TO LOOK FOR EVIDENCE OF EOSINOPHILIC ESOPHAGITIS. THEN HE PASSED THE 20 MM BALLOON DILATOR, BLEW IT UP TO 25MM/HG, HELD FOR ABOUT 30 SECONDS, AND THEN DEFLATED IT. THERE WAS NO SIGNIFICANT BLEEDING AT THIS TIME. THEN HE BLEW AT UP TO 37MM/HG. THERE WAS SOME SPLITTING OF THE MUCOSA, HENCE THE USER DEFLATED THE BALLOON AND PULLED IT OUT. HE LOOKED AT THE MUCOSA AND IT APPEARED TO BE SPLIT, BUT THERE DID NOT APPEAR TO BE A THROUGH AND THROUGH SPLIT OF THE ESOPHAGUS. AT THIS POINT HE ASPIRATED AIR OUT OF THE STOMACH AND THE ESOPHAGUS, AND REMOVED THE SCOPE. IMMEDIATELY POST-OP THE PT WAS OKAY, BUT AFTER A SHORT TIME, SHE HAD CHEST DISCOMFORT ON A SCALE OF 3/10. A CHEST X-RAY WAS PERFORMED AND IT SHOWED PNEUMOMEDIASTINUM. THE PT WAS STATED ON IV ANTIBIOTICS. A CAT SCAN IS PERFORMED AND SHOWED NO EVIDENCE OF A LEAK. AFTER 3-4 HOURS POST PROCEDURE, THE PT EXPERIENCED INCREASED HEART RATE AND CHEST PAIN. PT WAS TRANSFERRED BY AMBULANCE TO ANOTHER HOSPITAL FOR CONTINUING CARE. THE PT WAS OBSERVED FOR 4 DAYS, AND HAD 2 CONTRAST STUDIES THAT SHOWED NO EVIDENCE OF A LEAK. THE PT WAS DISCHARGED HOME WITH MEDICATION MANAGEMENT AND A FOLLOW UP APPOINTMENT WITH THE GASTROENTEROLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA II GI VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORPORATION GIF-H180J NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization CONMED 20 MM BALLOON DILATOR