BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ELECTROSURGICAL KNIFE

    MDR report key: 11907008 · Received May 31, 2021

    Report

    Report Number
    8010047-2021-06904
    Event Type
    Injury
    Date Received
    May 31, 2021
    Report Date
    May 31, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    KNS
    PMA / PMN Number
    K092309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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 "COMPARATIVE STUDY ON OUTCOMES OF ADVANCED KNIFE AND IT KNIFE IN ESOPHAGEAL ESD L". THE LITERATURE REPORTED THE RESULT OF 223 PATIENTS WITH SUPERFICIAL ESOPHAGEAL CANCER OF ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE USING THE OLYMPUS "IT KNIFE" BETWEEN OCTOBER 2016 TO MARCH 2019. IN THE LITERATURE, IT WAS REPORTED COMPLICATION AS FOLLOWS; INTRAOPERATIVE PERFORATION (1 CASE). ADVERSE EVENTS (NOT DETAILED) 3.7%. THERE ARE NOT MENTIONED THAT THESE COMPLICATIONS WERE RELATED TO THE SUBJECT DEVICE. OF THESE, OMSC ASSUMES THAT THE "ADVERSE EVENTS" COULD NOT BE IDENTIFIED AS SERIOUS BECAUSE THERE IS NO INDICATION IN THE LITERATURE. OMSC ASSUMES THAT THE "INTRAOPERATIVE PERFORATION" WAS RELATED TO THE SUBJECT DEVICE AND MAY HAVE BEEN SERIOUS EVENT BECAUSE THE PROCEDURE WAS DISCONTINUED. THEREFORE, OMSC ASSUMES THAT THE "INTRAOPERATIVE PERFORATION" 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 PERFORATION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805737 SINGLE USE ELECTROSURGICAL KNIFE SINGLE USE ELECTROSURGICAL KNIFE KNS OLYMPUS MEDICAL SYSTEMS CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other