BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ELECTROSURGICAL KNIFE

    MDR report key: 11917014 · Received June 1, 2021

    Report

    Report Number
    8010047-2021-06969
    Event Type
    Injury
    Date Received
    June 1, 2021
    Report Date
    June 2, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    KNS
    PMA / PMN Number
    K171158
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. SINCE THE SERIAL NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HOWEVER, OMSC HAS ONLY SHIPPED DEVICES THAT PASSED THE INSPECTION. IN THE LITERATURE, THERE IS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "REVIEW ARTICLE CURRENT STATUS AND PROSPECTS OF ENDOSCOPIC RESECTION TECHNIQUE FOR COLORECTAL TUMORS" THE LITERATURE REPORTED THE RESULT OF 22 PATIENTS WITH COLORECTAL CANCER OF ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE USING THE OLYMPUS "DUAL KNIFE J" OR "HOOK KNIFE" OR "IT KNIFE 2" BETWEEN (B)(6) 2011 AND (B)(6) 2020. IN THE LITERATURE, IT WAS REPORTED COMPLICATION AS FOLLOWS; HEMORRHAGE 5ML. INTRAOPERATIVE INJURY OF THE TERMINAL ILEUM (1 CASE). THERE ARE NOT MENTIONED THAT THESE COMPLICATIONS WERE RELATED TO THE SUBJECT DEVICE. OF THESE, OMSC ASSUMES THAT THE "HEMORRHAGE" COULD NOT BE IDENTIFIED AS SERIOUS BECAUSE THERE IS NO INDICATION IN THE LITERATURE. IN ADDITION, "INTRAOPERATIVE DAMAGE TO THE TERMINAL ILEUM" HAS BEEN TRANSFERRED TO LAPAROSCOPIC ILEAL RESECTION. THE LITERATURE STATES THAT "WE SPECULATED THAT THE REASON FOR THE INJURY WAS THE STRONG ADHESION BETWEEN THE TERMINAL ILEUM AND THE APPENDIX DUE TO PREVIOUS ASYMPTOMATIC APPENDICITIS." THOUGH, OMSC ASSUMES THAT THE "INTRAOPERATIVE INJURY OF THE TERMINAL ILEUM" MIGHT BE RELATED TO THE SUBJECT DEVICE AND SERIOUS EVENTS. THEREFORE, OMSC ASSUMES THAT THE "INTRAOPERATIVE INJURY OF THE TERMINAL ILEUM" WAS AN ADVERSE EVENT TO SUBMIT. BASED ON THE AVAILABLE INFORMATION, SPECIFIC INFORMATION ON THE SUBJECT DEVICE AND THE PATIENTS WERE NOT PROVIDED. THERE IS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION. OMSC WILL SUBMIT ONE MEDICAL DEVICE REPORT (MDR) OF THE SUBJECT DEVICE FOR THE "INTRAOPERATIVE INJURY OF THE TERMINAL ILEUM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812280 SINGLE USE ELECTROSURGICAL KNIFE KNS OLYMPUS MEDICAL SYSTEMS CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention