BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 12310983 · Received August 11, 2021

    Report

    Report Number
    8010047-2021-10115
    Event Type
    Injury
    Date Received
    August 11, 2021
    Date of Event
    July 13, 2021
    Report Date
    November 20, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    UDI-DI
    04953170202285
    PMA / PMN Number
    K100584
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO ANY OF THE OLYMPUS LOCATIONS. THEREFORE, OLYMPUS COULD NOT INVESTIGATE THE SUBJECT DEVICE. DURING INVESTIGATION, THE FOLLOWING INFORMATION WAS OBTAINED. -THE PROCEDURE STARTED AFTER THE PATIENT HAD ANALGESIA. -THE PROCEDURE PASSES WITHOUT ANY INDICATIONS OF POSSIBLE COMPLICATIONS AND THE ENDOSCOPIC EXAMINATION IS COMPLETED WITH THE SAME DEVICE -THE DOCTOR, IN AGREEMENT WITH THE ANESTHESIOLOGY TEAM, REFERRED THE PATIENT TO THE ANESTHESIOLOGY TEAM AT THE CLINIC FOR ANESTHESIOLOGY, RESUSCITATION AND INTENSIVE CARE FOR FURTHER OBSERVATION DUE TO THE APPLICATION OF ANALGESIA. -AS A RESULT OF THE OBSERVATION, THE PATIENT WAS DIAGNOSED WITH STROKE, VASCULAR COMPLICATIONS, HEMIPLEGIA. -THERE WAS NO NONCONFORMITY OF THE SCOPE. -THERE WAS NO RELATION BETWEEN THE SCOPE AND THE EVENT. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. BASED ON THE ADDITIONAL INFORMATION, IT WAS REPORTED THAT THERE WAS NO NONCONFORMITY OF THE SCOPE, AND NO RELATION BETWEEN THE SCOPE AND THE EVENT. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO ANY OF THE OLYMPUS LOCATIONS. THEREFORE, OLYMPUS COULD NOT INVESTIGATE THE SUBJECT DEVICE. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER FACILITY THAT DURING THE THERAPEUTIC GASTROSCOPY USING THE SUBJECT DEVICE AT THE USER FACILITY, IT WAS FOUND THAT THE THROAT OF THE PATIENT RUPTURED. THE PATIENT WAS IN CRITICAL STATE. THE USER FACILITY COMPLETED THE PROCEDURE USING THE SUBJECT DEVICE. THE USER DID NOT COMPLAIN ABOUT THE SUBJECT DEVICE OR ITS FUNCTION. THERE WERE NO REPORTS REGARDING THE EXTENSION OF THE PROCEDURE, FURTHER PATIENT OUTCOME OR INJURY ASSOCIATED WITH THIS EVENT, OR THE CAUSAL RELATIONSHIP BETWEEN THE SUBJECT DEVICE AND THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202843 EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-H180 04953170202285

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| R