BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ELECTROSURGICAL KNIFE KD-612

    MDR report key: 11906989 · Received May 31, 2021

    Report

    Report Number
    8010047-2021-06902
    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 "OUTCOME OF ESOPHAGEAL ESD IN PATIENTS TAKING ANTITHROMBOTIC DRUGS" THE LITERATURE REPORTED THE RESULT OF 1126 PATIENTS WITH FLAT EPITHELIAL CARCINOMA OF THE ESOPHAGUS OF ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE USING THE OLYMPUS "IT KNIFE NANO" BETWEEN (B)(6) 2011 TO (B)(6) 2020. IN THE LITERATURE, IT WAS REPORTED COMPLICATION AS FOLLOWS; INTRAOPERATIVE PERFORATION (10 CASES). DELAYED BLEEDING (7 CASES). DELAYED PERFORATION (1 CASE). THERE ARE NOT MENTIONED THAT THESE COMPLICATIONS WERE RELATED TO THE SUBJECT DEVICE. OF THESE, DELAYED BLEEDING AND DELAYED PERFORATION OCCURRED AFTER THE PROCEDURE. THEREFORE, OMSC IS NOT CONSIDERED TO BE RELATED TO THE SUBJECT DEVICE. OMSC ASSUMES THAT THE "INTRAOPERATIVE PERFORATION" MIGHT BE RELATED TO THE SUBJECT DEVICE AND SERIOUS EVENTS. 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
    805509 SINGLE USE ELECTROSURGICAL KNIFE KD-612 SINGLE USE ELECTROSURGICAL KNIFE KNS OLYMPUS MEDICAL SYSTEMS CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other