BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE INJECTOR NM600/610

    MDR report key: 14346455 · Received May 10, 2022

    Report

    Report Number
    8010047-2022-07968
    Event Type
    Injury
    Date Received
    May 10, 2022
    Date of Event
    November 19, 2018
    Report Date
    June 24, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FBK
    UDI-DI
    04953170422829
    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

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. THE LITERATURE ARTICLE IS ATTACHED FOR ADDITIONAL INFORMATION. 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 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 TITLED "TREATMENT RESULTS OF ENDOSCOPIC MUCOSAL RESECTION WITH A LIGATION DEVICE FOR DUODENAL NEUROENDOCRINE TUMORS". LITERATURE SUMMARY: THIS STUDY EXAMINED THE TREATMENT RESULTS OF ENDOSCOPIC MUCOSAL RESECTION WITH A LIGATION DEVICE (EMR-L) FOR THE REMOVAL OF DUODENAL NETS LOCATED IN THE SUBMUCOSAL LAYER WITHOUT METASTASIS. EMR-L CAN BE PERFORMED WITH LESS TECHNICAL SKILL, AND THE LIGATION DEVICE REDUCES THE RATE OF POSITIVE VERTICAL MARGIN. THE EN BLOC RESECTION RATE AND ENDOSCOPIC COMPLETE RESECTION RATE WERE BOTH (B)(4). COMPLETE RESECTION WAS ACHIEVED PATHOLOGICALLY IN 7 LESIONS ((B)(4)). THE VERTICAL MARGINS WERE NEGATIVE IN ALL CASES. LYMPHATIC VESSEL INVASION WAS OBSERVED IN THREE PATIENTS, ALL OF WHOM UNDERWENT ADDITIONAL SURGERY WITH LYMPH NODE DISSECTION (ONE OF THEM ALSO EXHIBITED BLOOD VESSEL INVASION AND A POSITIVE HORIZONTAL MARGIN). NO EVIDENCE OF RESIDUAL TUMORS OR LYMPH NODE METASTASIS WAS OBSERVED IN ANY OF THE PATIENTS. NO RECURRENCE WAS OBSERVED IN ANY OF THE 10 PATIENTS (MEAN FOLLOW-UP PERIOD: 18.6 MONTHS). ONE PATIENT ((B)(4)) EXPERIENCED INTRAOPERATIVE BLEEDING. PERFORATION OCCURRED IN 1 PATIENT ((B)(4)), BUT THE CONDITION WAS MANAGED WELL BY CONSERVATIVE THERAPY. EMR-L WAS AN ACCEPTABLE METHOD FOR ENDOSCOPICALLY RESECTING SUBMUCOSAL DUODENAL NETS, AND THE NETS RESECTED BY EMR-L WERE TUMOR-NEGATIVE IN THE VERTICAL MARGINS TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: INTRAPROCEDURE BLEEDING - (1), PERFORATION - (1). THIS ARTICLE INCLUDES 5 REPORTS AS FOLLOWS: PATIENT IDENTIFIER (B)(4) FOR GIF-Q260J, PATIENT IDENTIFIER (B)(4) FOR NM-610L-0423, PATIENT IDENTIFIER (B)(4) FOR SD-210L-10, PATIENT IDENTIFIER (B)(4) FOR UM-S20-20R, PATIENT IDENTIFIER (B)(4) FOR HX-202LR. THIS REPORT IS 2 OF FOR PATIENT IDENTIFIER (B)(4) FOR (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1376149 SINGLE USE INJECTOR NM600/610 INJECTOR AND SHEATHSET FBK OLYMPUS MEDICAL SYSTEMS CORP. NM-610L-0423 UNKNOWN(LITERATURE) 04953170422829

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other UNKNOWN SERIAL/LOT NUMBERS: (B))(6).| UNKNOWN SERIAL/LOT NUMBERS:(B)(6).