BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INJECTOR

    MDR report key: 16464029 · Received March 1, 2023

    Report

    Report Number
    9614641-2023-00281
    Event Type
    Injury
    Date Received
    March 1, 2023
    Date of Event
    December 17, 2022
    Report Date
    March 23, 2023
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    FBK
    PMA / PMN Number
    K011484
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 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 NEW INFORMATION ADDED TO B5. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED, "USEFULNESS OF THE COMBINED ORTHODONTIC RUBBER BAND AND CLIP METHOD FOR GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION." BACKGROUND AND AIMS: EFFECTIVE TRACTION IS AN IMPORTANT PREREQUISITE FOR SUCCESSFUL ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). THE COMBINED ORTHODONTIC RUBBER BAND (ORB) AND CLIP METHOD WAS EFFECTIVE IN COLORECTAL CANCER ESD. TO DATE, THE METHOD WAS NOT REPORTED IN GASTRIC ESD. THIS STUDY AIMED TO INVESTIGATE ITS EFFICACY AND SAFETY FOR GASTRIC NEOPLASMS ESD. METHODS: WE RETROSPECTIVELY ANALYZED DATA OF 118 PATIENTS WITH GASTRIC NEOPLASMS TREATED BY ESD FROM NOVEMBER 2020 TO APRIL 2022, 43 BY ORB-ESD AND 75 BY THE CONVENTIONAL ESD. THE PRIMARY OUTCOME MEASURE WAS THE ESD PROCEDURE TIME. CLINICAL DATA ON EFFICACY AND SAFETY WERE ALSO COLLECTED AND ANALYZED. PROPENSITY SCORE MATCHING (PSM) MATCHED THE PATIENTS IN BOTH GROUPS. RESULTS: PSM SUCCESSFULLY MATCHED 31 PAIRS OF PATIENTS. THE ORB-ESD OPERATION TIME WAS SHORTER (MEDIAN [INTERQUARTILE RANGE], 35 [30¿48] VS. 49 [40¿70] MIN, P0.05). CONCLUSIONS: COMPARED TO THE CONVENTIONAL ESD, ORB-ESD SIGNIFICANTLY REDUCED THE PROCEDURE TIME AND INCREASED THE DISSECTION SPEED, PROVING BENEFICIAL TO GASTRIC ESD. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: [ORB-ESD GROUP] DELAYED BLEEDING - 1 PATIENT, [CONVENTIONAL ESD] DELAYED BLEEDING - 3 PATIENTS. THIS LITERATURE ARTICLE REQUIRES 4 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6) (NM-4U-1). (B)(6) KD-650L). (B)(6) (FD-410LR). (B)(6) (GIF-Q260J). 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.

    Description of Event or Problem · 0

    THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: THERE WAS NO OLYMPUS DEVICE INVOLVED IN THE EVENTS DESCRIBED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1147850 INJECTOR INJECTOR FBK AOMORI OLYMPUS CO., LTD. NM-4U-1 UNKNOWN(LITERATURE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other NON-OLYMPUS DEVICE - CLIP| NON-OLYMPUS DEVICE - KNIFE (MK-T-2-195)| NON-OLYMPUS DEVICE - TRANSPARENT CAP| NON-OLYMPUS DEVICE - VIO200S (GENERATOR)