BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 14760938 · Received June 21, 2022

    Report

    Report Number
    8010047-2022-10501
    Event Type
    Death
    Date Received
    June 21, 2022
    Date of Event
    June 21, 2021
    Report Date
    October 18, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    UDI-DI
    04953170305290
    PMA / PMN Number
    K131780
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE DEFINITIVE CAUSE OF THE USER'S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. THE INVESTIGATION IS ONGOING. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIPT OF ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL AND/OR LOT NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT CANNOT BE CONFIRMED. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. THIS SUPPLEMENTAL REPORT INCLUDES INFORMATION ADDED TO B3, D4 AND D8. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    SURGERY: TEN YEAR ANALYSIS IN A (B)(6) CENTER,¿ PATIENTS EXPERIENCED ADVERSE EFFECTS DURING OR AFTER PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS ADVERSE EVENTS WITH GIF-H180. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS DEATHS WITH GIF-H180. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS ADVERSE EVENTS WITH GIF-H190. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS DEATHS WITH GIF-H190. BACKGROUND/AIMS: ANASTOMOTIC LEAKAGE AFTER ESOPHAGEAL SURGERY REMAINS A FEARED COMPLICATION. DURING THE LAST DECADE, MANAGEMENT OF THIS COMPLICATION CHANGED FROM SURGICAL REVISION TO A MORE CONSERVATIVE AND ENDOSCOPIC APPROACH. HOWEVER, THE TREATMENT REMAINS CONTROVERSIAL AS THE INDICATIONS FOR CONSERVATIVE, ENDOSCOPIC, AND SURGICAL APPROACHES REMAIN NON-STANDARDIZED. METHODS: BETWEEN 2010 AND 2020, ALL PATIENTS WHO UNDERWENT IVOR LEWIS ESOPHAGECTOMY FOR UNDERLYING MALIGNANCY WERE INCLUDED IN THIS STUDY. THE DATA OF 28 PATIENTS DIAGNOSED WITH ANASTOMOTIC LEAK WERE FURTHER ANALYZED. RESULTS: AMONG 141 PATIENTS WHO UNDERWENT RESECTION, 28 (19.9%) DEVELOPED AN ANASTOMOTIC LEAK, EIGHT (28.6%) OF WHOM DIED. THIRTEEN PATIENTS WERE TREATED WITH ENDOLUMINAL VACUUM THERAPY (EVT), SEVEN PATIENTS WITH SELF-EXPANDING METAL STENTS (SEMS) FOUR PATIENTS WITH PRIMARY SURGERY, ONE PATIENT WITH A HEMOCLIP, AND THREE PATIENTS WERE TREATED CONSERVATIVELY. EVT ACHIEVED CLOSURE IN 92.3% OF THE PATIENTS WITH A LARGE DEFECT AND NO EVT-RELATED COMPLICATIONS. SEMS THERAPY WAS SUCCESSFUL IN CLINICALLY STABLE PATIENTS WITH SMALL DEFECT SIZES. CONCLUSIONS: EVT CAN BE SUCCESSFULLY APPLIED IN THE TREATMENT OF ANASTOMOTIC LEAKAGE IN CRITICALLY ILL PATIENTS, WHILE SEMS SHOULD BE LIMITED TO CLINICALLY STABLE PATIENTS WITH A SMALL DEFECT SIZE. SURGERY IS ONLY WARRANTED IN PATIENTS WITH SEPSIS WITH GRAFT NECROSIS. THIRTEEN PATIENTS (46.4%) WITH A MEDIASTINAL LEAKAGE CAVITY (EXTRALUMINAL CAVITY) WERE TREATED WITH EVT. THE MEDIAN TIME TO DIAGNOSIS OF ANASTOMOTIC LEAK AFTER THE PRIMARY SURGERY WAS 8 DAYS. ALL PATIENTS WITH AN EXTRALUMINAL CAVITY WERE TREATED USING EVT, AND ALL OF THOSE WITHIN THE EVT GROUP WHO DIED HAD AN EXTRALUMINAL CAVITY. NO EVT-RELATED COMPLICATIONS WERE OBSERVED. THE MEDIAN TIME FOR EVT WAS 24.5 DAYS (RANGE: 8¿80 DAYS) WITH A MEDIAN OF FIVE EXCHANGED SPONGES (RANGE: 4¿18). THE MEDIAN DEFECT SIZE WAS 15 MM, AND THE MEDIAN DEFECT WAS LOCATED 26 CM FROM THE UPPER INCISOR. EIGHT PATIENTS WERE SUCCESSFULLY TREATED (61.5%), WHILE FIVE PATIENTS PASSED AWAY. HOWEVER, COMPLETE CLOSURE OF THE DEFECT WAS ACHIEVED IN 12 PATIENTS (92.3%). FIVE PATIENTS NEEDED SURGICAL REVISION DURING EVT, AND 4 OF THOSE PATIENTS DIED. ALL OF THESE PATIENTS REQUIRED SURGERY DUE TO COMPLICATIONS THAT COULD NOT BE ATTRIBUTED TO EVT. THE REASONS FOR SURGERY WERE ISCHEMIA OF THE COLON, NECROSIS OF THE PANCREAS, POSTOPERATIVE INCARCERATED HIATAL HERNIA, AND HEMOTHORAX. THE MEDIAN ICU/IMC STAY WAS 38 DAYS (RANGE: 9¿193 DAYS), WITH A MEDIAN HOSPITAL STAY OF 74 DAYS (RANGE: 9¿193 DAYS). THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1755673 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-H190 04953170305290

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death