BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA ELITE SMALL INTESTINAL VIDEOSCOPE

    MDR report key: 14655577 · Received June 10, 2022

    Report

    Report Number
    8010047-2022-09837
    Event Type
    Injury
    Date Received
    June 10, 2022
    Report Date
    August 1, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE A CORRECTION AND ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE 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. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE: EXAMINATION OF TREATMENT OF BILE DUCT STONES USING SHORT-SBE IN POSTOPERATIVELY RECONSTRUCTED INTESTINAL TRACT CASES. [LITERATURE SUMMARY] [PURPOSE] IN OUR HOSPITAL, POSTOPERATIVELY RECONSTRUCTED INTESTINAL TRACT CASES ON THE OTHER HAND, WE INVESTIGATED THE USEFULNESS OF ENDOSCOPIC BILE DUCT STONE TREATMENT USING SHORT-SBE, WHICH IS PERFORMING ERCP-RELATED PROCEDURES USING SHORT SINGLE-BALLOON ENDOSCOPY (SHORT-SBE). METHODS: THE SUBJECTS WERE 233 PATIENTS AND 398 PATIENTS WHO UNDERWENT ERCP-RELATED PROCEDURES USING SHORT-SBE (EFFECTIVE LENGTH 152 CM, FORCEPS DIAMETER 3.2 MM, OLYMPUS) FROM JULY 2013 TO SEPTEMBER 2021 FOR STONE TREATMENT. THE RECONSTRUCTION METHOD WAS R-YLO 1 CASE, 148 CASES. B-II 19 CASES, 29 CASES, CHILD MODIFIED METHOD 28 CASES, 80 CASES. SUCCESS RATE OF REACHING THE SITE, (2) SUCCESS RATE OF DEEP BILE DUCT INFUSION, (3) COMPLETION RATE OF STONE REMOVAL. (4) TREATMENT CONTENT, (5) INCIDENT. [RESULTS] (1) SUCCESS RATE OF REACHING THE TARGET SITE , 97.3% (250/257), R-Y95.3% (141/148), B-H100% (29/29). CHILD MODIFIED 100% (80/80), LONGSCOPE AT A LATER DATE IN RY CASES BY USING (SIF-Q260, EFFECTIVE LENGTH 152 CM, FORCEPS DIAMETER 2.8 MM, OLYMPUS), IT WAS POSSIBLE TO REACH THE TARGET SITE IN 3 CASES. (2) DEEP BILE DUCT INFUSION OUT OF 250 REACHABLE CASES THE SUCCESS RATE WAS 96% (240/250), R-Y94.3% (133/141), B-II96.6% (28/29), CHILD MODIFIED 98.8% (79/80), FIVE OF THE 10 UNSUCCESSFUL DEEP INFUSIONS WERE REEXAMINED AT A LATER DATE AND COULD BE DEEPLY INFUSED. FOR DEEP BILE DUCT INFUSION, CANNULATION USING THE RETROFLEX POSITION OR PANCREATIC DUCT WAS USEFUL. (3) STONE REMOVAL THE COMPLETION RATE WAS 89.2% (132/148). (4) TREATMENTS WERE EST 3 CASES, EPBD 11 CASES, EPLBD 69 CASES (INCLUDING EST + EPLBD 9 CASES), AND BILE DUCT AIR INTESTINAL ANASTOMOSIS DILATION 41 CASES. STACKED STONES, EPLBD WAS USEFUL IN GIANT STONES. INTRAHEPATIC STONE CASES WERE SOMETIMES USEFUL WITH ORAL CHOROIDOSCOPIC EHL. (5) INCIDENTS WERE 6.6% (17/257) OVERALL AND 3.5% PANCREATITIS (5). 9/257), CHOLANGITIS 19% (5/257), PERFORATION 1.2% (3/257). [CONCLUSION] BILE DUCT STONE TREATMENT USING SHORT-SBE IN THE POSTOPERATIVELY RECONSTRUCTED INTESTINAL TRACT WAS SAFE BECAUSE THE ACCIDENTS WERE WITHIN THE PERMISSIBLE RANGE. FURTHER IMPROVEMENTS IN ENDOSCOPES AND TREATMENT TOOLS WERE MADE TO IMPROVE THE TREATMENT SUCCESS RATE. THE TIPS OF THE PROCEDURE, INCLUDING HOW TO DEAL WITH DIFFICULT CASES OF STONE REMOVAL, WILL BE SHOWN IN A VIDEO. [TYPE OF ADVERSE EVENTS / NUMBER OF PATIENTS] PANCREATITIS N = 9, CHOLANGITIS N = 5, PERFORATION N = 3 . THIS ARTICLE INCLUDES 2 REPORTS: PATIENT IDENTIFIER (B)(6) SIF-H290S. PATIENT IDENTIFIER (B)(6) SIF-Q260. THIS IS REPORT 1 OF 2 FOR PATIENT IDENTIFIER (B)(6) SIF-H290S WAS SELECTED AS A REPRESENTATIVE PRODUCT FOR SHORT-SBE FORCEPS.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR: IN THE MEDICAL OPINION OF THE AUTHOR, THE OLYMPUS DEVICES DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENTS. THERE WAS NO MALFUNCTION OF THE OLYMPUS DEVICE. THE AUTHOR STATED THE COMPLICATIONS WERE TREATED WITH CLIPPING PROCEDURES AND NO SURGICAL APPROACH WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2155619 EVIS LUCERA ELITE SMALL INTESTINAL VIDEOSCOPE SMALL INTESTINAL VIDEOSCOPE FDA OLYMPUS MEDICAL SYSTEMS CORP. SIF-H290S

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other