BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE

    MDR report key: 9849898 · Received March 18, 2020

    Report

    Report Number
    8010047-2020-01816
    Event Type
    Death
    Date Received
    March 18, 2020
    Report Date
    October 23, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDA
    UDI-DI
    04953170242526
    PMA / PMN Number
    K071254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. PLEASE SEE THE UPDATES IN SECTIONS: G4, G7, H2, H6 AND H10. THE LEGAL MANUFACTURER REVIEWED THE CONTENTS OF THIS COMPLAINT. THE EXACT ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. AS THERE WAS NO REPORTED MALFUNCTION OF THE SUBJECT DEVICE RELATED TO THE EVENTS. IN ADDITION, THERE WAS NO PROOF/DESCRIPTION TO SHOW THE ASSOCIATION BETWEEN THE ADVERSE EVENTS AND THE SUBJECT DEVICE.

    Additional Manufacturer Narrative · 1

    THE ARTICLE DID NOT SPECIFY THE SERIAL NUMBER OF THE REFERENCED SCOPE; THEREFORE, IT IS UNKNOWN IF THE SCOPE WAS RETURNED FOR REPAIR/SERVICE. AN INSTRUMENT HISTORY IS UNABLE TO BE PERFORMED. FURTHERMORE, THE STUDY'S PHYSICIAN PROVIDED A PROBABLE CAUSE OF THE REPORTED DEATH STATING THAT "IT WAS HYPOTHESIZED THAT THE PATIENT'S DEATH MAY HAVE BEEN DUE TO AIR EMBOLISM, ALTHOUGH A PULMONARY EMBOLISM, MUCUS PLUG, ARRHYTHMIA, AND MYOCARDIAL INFARCTION ARE ALSO POSSIBILITIES. PROLONGED MANIPULATION AND ENDOSCOPY TIME MAY RESULT IN MORE LEAKAGE OF AIR THROUGH A NEWLY FORMED GASTROSTOMY INTO THE PERITONEUM. HOWEVER, THE JEJUNAL EXTENSION INSERTION USING A SINGLE-BALLOON ENTEROSCOPE IS ACTUALLY FASTER THAN THE STANDARD TECHNIQUE BECAUSE OF THE LACK OF RETROGRADE MIGRATION, AND THUS IT WAS FELT THAT THIS DID NOT CONTRIBUTE TO THE ADVERSE OUTCOME IN THIS PATIENT."

    Description of Event or Problem · 1

    OLYMPUS RECEIVED AN ARTICLE TITLED ¿INSERTION OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBES WITH JEJUNAL EXTENSIONS USING THE ¿WEDGE¿ TECHNIQUE: A NOVEL METHOD TO PREVENT RETROGRADE TUBE MIGRATION INTO THE STOMACH¿. THERE WERE 17 PATIENTS ON THE STUDY. THE ARTICLE REPORTED THAT TWO ADVERSE EVENTS OCCURRED DUE TO PEG INSERTION ALTHOUGH NONE WERE RELATED TO THE JEJUNAL EXTENSION INSERTION ITSELF USING THE WEDGE TECHNIQUE. ONE FEMALE PATIENT DEVELOPED ASYMPTOMATIC PNEUMOPERITONEUM AFTER THE PROCEDURE. SHE WAS DISCHARGED 6 HOURS LATER WHEN A REPEAT ABDOMINAL X-RAY SHOWED RESOLUTION OF MOST OF THE FREE AIR. SHE REMAINED ASYMPTOMATIC UNTIL NOON THE FOLLOWING DAY WHEN SHE TOOK A NAP WITH HER HUSBAND, COUGHED ONCE, AND STOPPED BREATHING. RESUSCITATION WAS NOT PERFORMED, FOLLOWING THE PATIENT¿S PRIOR WISHES. AN AUTOPSY WAS OFFERED BUT DECLINED. THIS IS PATIENT 2 OF 2 ADVERSE EVENTS FOR THE SUBJECT STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311019 EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE SMALL INTESTINAL VIDEOSCOPE FDA OLYMPUS MEDICAL SYSTEMS CORP. SIF-Q180 04953170242526

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death