BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE INJECTOR NM600/610

    MDR report key: 23312047 · Received October 16, 2025

    Report

    Report Number
    3003637092-2025-00152
    Event Type
    Injury
    Date Received
    October 16, 2025
    Date of Event
    April 18, 2022
    Report Date
    October 16, 2025
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FBK
    PMA / PMN Number
    K153625
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THE LITERATURE DESCRIBED ¿NEEDLEMASTER¿¿, OLYMPUS SELECTED ¿NM-600L-0425¿ AS A REPRESENTATIVE PRODUCT. THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT CANNOT BE CONFIRMED. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS: (B)(6).

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "RED DICHROMATIC IMAGING REDUCES BLEEDING AND HEMATOMA DURING SUBMUCOSAL INJECTION IN ESOPHAGEAL ENDOSCOPIC SUBMUCOSAL DISSECTION." LITERATURE SUMMARY: ABSTRACT: BACKGROUND: BLEEDING AND HEMATOMA FORMATION DURING SUBMUCOSAL INJECTION IN ESOPHAGEAL ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) REDUCE THE VISIBILITY OF THE SUBMUCOSA. RED DICHROMATIC IMAGING (RDI) IS AN ENDOSCOPIC TECHNIQUE THAT PROVIDES BETTER VISUALIZATION OF THE DEEP SUBMUCOSAL BLOOD VESSELS. WE SPECULATED THAT BLOOD VESSEL INJURY COULD BE AVOIDED WITH RDI. THIS PILOT STUDY EVALUATED THE ROLE OF RDI IN PREVENTING BLEEDING AND HEMATOMA FORMATION DURING ESOPHAGEAL ESD. METHODS: THIS WAS A SINGLE-CENTER RETROSPECTIVE OBSERVATIONAL STUDY. WE EXAMINED 60 PATIENTS WHO UNDERWENT ESD WITH WHITE LIGHT IMAGING (WLI) AND RDI. A SINGLE ENDOSCOPIST REVIEWED ALL OF THE SURGICAL VIDEOS TO DOCUMENT THE INCIDENCE AND SEVERITY OF BLEEDING EPISODES. EIGHTEEN VIDEOS PROVIDED ADEQUATE QUALITY AND DETAIL, AND THE NUMBER OF BLOOD VESSELS TRAVERSING THE MUCOSAL INCISION LINES OF THE LESIONS IN THESE VIDEOS WAS EVALUATED UNDER WLI AND RDI. RESULTS: THE WLI GROUP HAD A SIGNIFICANTLY HIGHER INCIDENCE OF HEMATOMAS PER UNIT AREA COMPARED TO THE RDI GROUP (0.18/CM2 [RANGE 0¿0.38] VS. 0 [0¿0.18]/CM2, P = 0.024). THE WLI GROUP ALSO HAD A SIGNIFICANTLY HIGHER INCIDENCE OF TOTAL BLEEDING EPISODES COMPARED TO THE RDI GROUP (42.9% [RANGE 21.7¿60.4] VS 16.7% [RANGE 13.8¿22.9], P < 0.001). SIGNIFICANTLY MORE BLOOD VESSELS WERE VISIBLE UNDER RDI COMPARED TO WLI (5 [RANGE 4¿8] VS. 2 [RANGE 1¿5], P = 0.0020). TYPE OF ADVERSE EVENT / NUMBER OF PATIENTS: INTRAPROCEDURAL PERFORATION - 2 PATIENTS. CONCLUSION: RDI REDUCED THE INCIDENCE OF BLEEDING AND HEMATOMA FORMATION DURING SUBMUCOSAL INJECTION IN ESOPHAGEAL ESD. IT WAS ASSUMED THAT THE IMPROVEMENT OF BLOOD VESSEL VISIBILITY BY RDI MIGHT HAVE CONTRIBUTED TO THE RESULT. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION IDENTIFIED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2665514 SINGLE USE INJECTOR NM600/610 INJECTOR AND SHEATHSET FBK OLYMPUS MEDICAL SYSTEMS CORP. NM-600L-0425 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown