BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 13269827 · Received January 17, 2022

    Report

    Report Number
    8010047-2022-01544
    Event Type
    Death
    Date Received
    January 17, 2022
    Report Date
    January 18, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    ODG
    UDI-DI
    04953170356346
    PMA / PMN Number
    K093395
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. SINCE THE SERIAL NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HOWEVER, OMSC HAS ONLY SHIPPED DEVICES THAT PASSED THE INSPECTION. IN THE LITERATURE, THERE IS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "EUS-GUIDED GASTROENTEROSTOMY WITH A LUMEN APPOSING SELF-EXPANDABLE METALLIC STENT RELIEVES GASTRIC OUTLET OBSTRUCTION ¿ A SCANDINAVIAN CASE". THE LITERATURE REPORTED THE RESULT OF 33 PATIENTS WITH MALIGNANT OR BENIGN GASTRIC OUTLET OBSTRUCTION WHO UNDERWENT ENDOSCOPIC ULTRASONOGRAPHY (EUS) -GUIDED GASTROENTEROSTOMY PROCEDURE USING OLYMPUS GF-UCT180 AND ANOTHER DEVICE. IN ADDITION, THE FOLLOWING DESCRIPTION OF THE PATIENT'S CLINICAL CONDITION IS PROVIDED. "THE PATIENTS WERE GENERALLY IN POOR CLINICAL CONDITION BEFORE THE EUS-GE WITH A MEDIAN AMERICAN SOCIETY OF ANESTHESIOLOGISTS (ASA) PHYSICAL STATUS SCORE OF 3 (RANGE 2¿4)." IN THE LITERATURE, THE FOLLOWING COMPLICATIONS HAVE BEEN REPORTED TO HAVE OCCURRED. (1) STENT DISPLACEMENT/MIGRATION (3 CASES). OMSC ASSUMED THAT THE EVENT (1) WAS NO DIRECT RELATIONSHIP WITH THE SUBJECT DEVICE. (2)-1 BLEEDING (THE BLEEDING WAS STOPPED BY PLACING AN ENDOSCOPIC HEMOCLIP) (1 CASE). OMSC ASSUMED THAT THE EVENT (2)-1 WAS NOT SERIOUS BASED ON THE STATEMENT IN THE LITERATURE THAT "THE BLEEDING WAS STOPPED BY PLACING AN ENDOSCOPIC HEMOCLIP". (2)-2 BLEEDING (THIS PATIENT SUBSEQUENTLY DIED FROM BLEEDING) (1 CASE). OMSC ASSUMED THAT THE EVENT (2)-2 WAS SERIOUS EVENT. (3)-1 LOWER RESPIRATORY INFECTIONS (ACQUIRED ASPIRATION PNEUMONIA) (1 CASE). (3)-2 LOWER RESPIRATORY INFECTIONS (DIED OF LOWER AIRWAY INFECTIONS) (2 CASES) . OMSC ASSUMED THAT THE EVENT (3)-1 AND (3)-2 WERE NO DIRECT RELATIONSHIP WITH LOWER RESPIRATORY TRACT INFECTIONS IN THE CARDIOVASCULAR BECAUSE THE PROCEDURE WAS AN EUS-GUIDED GASTROENTEROSTOMY. (4) RE-FEEDING SYNDROME (FATAL) (1 CASE). (5) TWO OR MORE ATTEMPTS/PUNCTURES (1 CASE). (6) DECEASED (22 CASES). OMSC ASSUMED THAT THESE EVENTS ((4), (5) AND (6)) WERE NO DIRECT RELATIONSHIP WITH THE SUBJECT DEVICE. BASED ON THE AVAILABLE INFORMATION, SPECIFIC INFORMATION ON THE SUBJECT DEVICE AND THE PATIENTS WERE NOT PROVIDED. THERE IS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION. HOWEVER, OMSC ASSUMES THAT "BLEEDING (THIS PATIENT SUBSEQUENTLY DIED FROM BLEEDING)" MIGHT BE RELATED TO THE SUBJECT DEVICE, AND THE SUBJECT DEVICE MIGHT BE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY BECAUSE THE LITERATURE DESCRIBED AS FOLLOWS, "THE SECOND PATIENT EXPERIENCED ACUTE BLEEDING FROM A PANCREATIC TUMOR DURING THE REMOVAL OF AN OCCLUDED DUODENAL STENT. THE STENT REMOVAL WAS DONE DURING THE SAME PROCEDURE AS THE EUS-GE. THIS PATIENT SUBSEQUENTLY DIED FROM BLEEDING." THEREFORE, OMSC DETERMINED THAT THE "BLEEDING (THIS PATIENT SUBSEQUENTLY DIED FROM BLEEDING)" WAS ADVERSE EVENT TO SUBMIT. OMSC WILL SUBMIT A MEDICAL DEVICE REPORT (MDR) DEPENDING ON THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151396 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORP. GF-UCT180 04953170356346

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| D