BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA ELITE SMALL INTESTINAL VIDEOSCOPE

    MDR report key: 15043513 · Received July 18, 2022

    Report

    Report Number
    9610595-2022-00060
    Event Type
    Injury
    Date Received
    July 18, 2022
    Date of Event
    November 7, 2021
    Report Date
    August 4, 2022
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    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 ADDITIONAL INFORMATION FROM THE AUTHOR AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. NEW INFORMATION WAS ADDED TO THE FOLLOWING FIELDS: B3, B5, H6, H10. 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 REPORT "SCISSOR-TYPE KNIFE PRECUT IN BALLOON ENTEROSCOPY¿ASSISTED ERCP FOR PATIENTS WITH DIFFICULT BILIARY CANNULATION AND SURGICALLY ALTERED ANATOMY (WITH VIDEO)." LITERATURE SUMMARY: THIS RETROSPECTIVE STUDY DESCRIBES THE SCISSOR-TYPE KNIFE PRECUT IN BALLOON ENTEROSCOPY¿ASSISTED ERCP FOR PATIENTS WITH DIFFICULT BILIARY CANNULATION AND SURGICALLY ALTERED ANATOMY. IN THIS STUDY, 125 PATIENTS WITH NATIVE DUODENAL PAPILLAE UNDERWENT BE-ERCP, AND THE PAPILLA WAS REACHED IN 116 PATIENTS. A SHORT-TYPE DOUBLE-BE (EI-580BT; FUJIFILM) OR SHORT-TYPE SINGLE-BE (SIF-H290S; OLYMPUS ) WAS USED FOR BE-ERCP. SKP WAS CONDUCTED USING THE SB KNIFE JR OR SB KNIFE JR2 (SUMITOMOBAKELITE) AND THE ELECTROSURGICAL UNIT (ESG-100; OLYMPUS ) WAS SET TO THE PULSECUT MODE AT 30 TO 40 W. THE SUCCESS RATE OF BILIARY CANNULATION WITH THE STANDARD CANNULATION WAS 67.2% (78/116), AND FURTHER IMPROVED TO 87.9% (102/116) WITH THE ADDITION OF NEEDKNIFE PRECUTTING. SKP WAS ATTEMPTED IN 12 PATIENTS. THE TECHNICAL SUCCESS RATE OF SKP WAS 66.7% (8/12); THUS, SKP INCREASED THE FINAL SUCCESS RATE OF BILIARY CANNULATION TO 94.8% (110/116). THE RATE OF ADVERSE EVENTS ASSOCIATED WITH SKP WAS 8.3% (1/12). MILD PANCREATITIS OCCURRED IN ONE PATIENT, WHO RECOVERED WITH CONSERVATIVE MANAGEMENT. THIS STUDY CONCLUDED THAT THE USE OF THE SKP TECHNIQUE FOR DIFFICULT BILIARY CANNULATION IN PATIENTS WITH SAA, WHICH MAY SERVE AS A USEFUL OPTION FOR SALVAGE CANNULATION DURING BE-ERCP. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: PANCREATITIS - 1 PATIENT: TREATED WITH CONSERVATIVE MANAGEMENT.

    Description of Event or Problem · 0

    THE AUTHOR RESPONDED TO A REQUEST FOR ADDITIONAL INFORMATION STATING THERE WAS NO MALFUNCTION OF THE OLYMPUS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959362 EVIS LUCERA ELITE SMALL INTESTINAL VIDEOSCOPE SMALL INTESTINAL VIDEOSCOPE FDA AIZU OLYMPUS CO., LTD. SIF-H290S

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other UNKNOWN SERIAL (B)(6)