BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE INJECTOR NM600/610

    MDR report key: 20043910 · Received August 22, 2024

    Report

    Report Number
    9614641-2024-01692
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    January 4, 2024
    Report Date
    August 28, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    FBK
    UDI-DI
    04953170278266
    PMA / PMN Number
    K153625
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. ADDITIONAL INFORMATION REQUESTED FROM AUTHOR; HOWEVER, ALL REQUESTED INFORMATION IS UNKNOWN. 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 EVENTS 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. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. THIS REPORT IS RELATED TO LINKED TO THE FOLLOWING PATIENT IDENTIFIERS: (B)(6). ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "EFFICACY AND SAFETY OF MC-003 SOLUTION FOR ENDOSCOPIC MUCOSAL OR SUBMUCOSAL RESECTION: A PROSPECTIVE, MULTICENTER, RANDOMIZED, TRIPLE-BLINDED, PARALLEL-GROUP, PHASE III STUDY." BACKGROUND AND AIMS: THE SAFETY AND EFFICACY OF SOLUTIONS FOR SUBMUCOSAL INJECTION ARE CRITICAL FOR ENDOSCOPIC RESECTION OF GASTRIC ADENOMAS OR EARLY GASTRIC CANCERS. ALTHOUGH SEVERAL INJECTABLE SOLUTIONS HAVE BEEN INTRODUCED FOR ENDOSCOPIC RESECTION, THEY HAVE SOME LIMITATIONS. WE AIMED TO COMPARE THE EFFICACY OF THE NEW SODIUM ALGINATE¿BASED SOLUTION MC-003 WITH THAT OF NORMAL SALINE (NS; 0.9% SODIUM CHLORIDE). METHODS: IN THIS RANDOMIZED, TRIPLE-BLIND STUDY, 70 PATIENTS WERE INITIALLY ENROLLED FOR EMR OR ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). THE MAIN OUTCOMES INCLUDED THE NEED FOR ADDITIONAL INJECTIONS, COMPLETION OF EN BLOC RESECTION, AND OCCURRENCE OF ADVERSE EVENTS. RESULTS: EACH GROUP ULTIMATELY INCLUDED 34 PATIENTS. COMPLETE EN BLOC RESECTIONS WERE ACHIEVED IN ALL PATIENTS (P Z 1.000). THE MC-003 GROUP HAD MORE PERI-NEOPLASM TISSUE FIBROSIS (P Z .056) AND NEEDED FEWER ADDITIONAL INJECTIONS FOR LESIONS >15 MM (P Z .037), LOCATED IN THE DISTAL PORTION OF THE STOMACH (P Z .007), AND DURING ESD PROCEDURES (P Z .001). THE ADVERSE EVENT RATE WAS COMPARABLE IN BOTH GROUPS. IT IS SERIOUS ACCORDING TO FOLLOWING DESCRIPTION. IN TERMS OF SEVERE ADVERSE EVENTS, ONE CASE OF DELAYED HOSPITAL DISCHARGE DUE TO MODERATE TO SEVERE GI BLEEDING OCCURRED ONLY IN THE NS GROUP (1 [2.9%] OF 34 CASES). CONCLUSIONS: MC-003 OUTPERFORMED NS IN REDUCING THE NEED FOR ADDITIONAL INJECTIONS DURING EN BLOC RESECTION, PARTICULARLY IN LARGER LESIONS LOCATED IN THE DISTAL PORTION OF THE STOMACH (WHERE MOST LESIONS WERE FOUND) DURING ESD PROCEDURES, WITHOUT INCREASING THE INCIDENCE OF SERIOUS ADVERSE EVENTS. MC-003 IS A PROMISING SUBMUCOSAL INJECTABLE SOLUTION IN REAL-WORLD CLINICAL SETTINGS. (GASTROINTEST ENDOSC 2024;100:36-45.) TYPE OF ADVERSE EVENTS (AE)/NUMBER OF PATIENTS MODERATE-SEVERE GASTRIC BLEEDING (1)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1581594 SINGLE USE INJECTOR NM600/610 INJECTOR AND SHEATHSET FBK AOMORI OLYMPUS CO., LTD. NM-600L-0423 04953170278266

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization D-201-10704, LOT UNKNOWN| KD-611L, LOT UNKNOWN| KD-620LR, LOT UNKNOWN| KD-655L, LOT UNKNOWN