BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE 3-LUMEN NEEDLE KNIFE V

    MDR report key: 15770768 · Received November 10, 2022

    Report

    Report Number
    9614641-2022-00588
    Event Type
    Injury
    Date Received
    November 10, 2022
    Date of Event
    January 7, 2022
    Report Date
    December 19, 2022
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    KNS
    UDI-DI
    04953170382703
    PMA / PMN Number
    K955247
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THE LITERATURE DESCRIBED "CUTTING KNIFE", OLYMPUS SELECTED "KD-V441M" WHICH WAS SHIPPED THE MOST IN THE AREA AND IN THE STUDY PERIOD. THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. THE LITERATURE ARTICLE IS ATTACHED FOR ADDITIONAL INFORMATION. HTTPS://DOI.ORG/10.1007/S00464-021-09000-0 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 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 E4. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "THE ASSESSMENT OF THE ASGE-GRADING SYSTEM OF ERCP: A LARGE-SAMPLE RETROSPECTIVE STUDY." THIS RETROSPECTIVE STUDY AIMED TO ASSESS THE ASSOCIATION BETWEEN THE DEGREE OF DIFFICULTY FOR ERCP AND THE RATES OF SUCCESS AND ADVERSE EVENT, IN TURN DEMONSTRATING THE VALIDITY AND PRACTICALITY OF THIS SYSTEM. A TOTAL OF 20,652 ERCP PROCEDURES PERFORMED DURING THE STUDY PERIOD WERE ANALYZED. THE OVERALL SUCCESS RATE INCREASED FROM 92.8% TO 94.0%, WHILE THE DISTRIBUTION OF PROCEDURES AND THE INCIDENCE OF COMPLICATIONS SHOWED LITTLE VARIATION. THE SUCCESS RATE REVEALED A SIGNIFICANTLY DECREASING TREND WITH INCREASING DIFFICULTY (RANGING FROM 55.6 TO 98.6%), MAINLY FOR BILIARY DISEASES. IN ADDITION, THE DIFFICULTY SCALE WAS NOT ASSOCIATED WITH ANY DIFFERENCES IN THE RATE OF ADVERSE EVENT, EXCEPT FOR THE PANCREATITIS FOR GRADE 1 PROCEDURES, WHICH HAD A LOW INCIDENCE. THIS STUDY CONCLUDED THAT THE ASGE-GRADING SYSTEM CAN HELP PREDICT THE SUCCESS RATE OF ERCP PROCEDURES BUT SHOWED POOR PERFORMANCE IN PREDICTING ADVERSE EVENTS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: COHORT - 1. PANCREATITIS - 511 PATIENTS. BLEEDING - 410 PATIENTS. CHOLANGITIS - 62 PATIENTS. PERFORATION - 26 PATIENTS. COHORT - 2. PANCREATITIS - 536 PATIENTS. BLEEDING - 412 PATIENTS. CHOLANGITIS - 83 PATIENTS. PERFORATION - 32 PATIENTS. THIS LITERATURE ARTICLE REQUIRES 3 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6)/KD-V441M, (B)(6)/JF-240 AND (B)(6)/JF-260V. THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER (B)(6). 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
    640247 SINGLE USE 3-LUMEN NEEDLE KNIFE V SINGLE USE 3-LUMEN NEEDLE KNIFE KNS AOMORI OLYMPUS CO., LTD. KD-V441M UNKNOWN(LITERATURE) 04953170382703

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other NON- OLYMPUS BALLOON, SN UNKNOWN| NON- OLYMPUS BASKET, SN UNKNOWN| NON- OLYMPUS C-ARM ERCP X-RAY, SN UNKNOWN| NON- OLYMPUS GUIDEWIRE, SN UNKNOWN| OLYMPUS JF-240, TJF-240 OR JF-260V, SN UNKNOWN