BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ELECTROSURGICAL KNIFE

    MDR report key: 11408496 · Received March 3, 2021

    Report

    Report Number
    8010047-2021-03269
    Event Type
    Injury
    Date Received
    March 3, 2021
    Report Date
    March 4, 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 LOT 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 WAS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION.

    Description of Event or Problem · 1

    ON FEBRUARY 2, 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED LITERATURE TITLED " PREDICTIVE FACTORS OF MILD AND SEVERE FIBROSIS IN COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION". THE PURPOSE WAS TO IDENTIFY THE PREDICTIVE FACTORS AND TO EXAMINE THE FEASIBILITY OF ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) FOR FIBROTIC LESIONS. IN THE LITERATURE, IT WAS REPORTED THAT 2 INTRAOPERATIVE PERFORATIONS WERE OBSERVED IN 518 PATIENTS WHICH UNDERWENT ESD FOR 558 COLORECTAL LESIONS AT OMORI RED CROSS HOSPITAL FROM APRIL 2012-SEPTEMBER 2018. WE COULD NOT IDENTIFY THE SEVERITIES AND THE OUTCOMES OF THE PERFORATIONS. THE ESD PROCEDURE WAS PERFORMED USING THE OLYMPUS¿S PRODUCTIONS; KNIFE (KD-650L, KD-630L), TRANSPARENT CAP (D-201-11802), AND SINGLE CHANNEL ENDOSCOPE (PCF-Q260 JI, GIF-Q260J). WE COULD NOT IDENTIFY WHAT KIND OF MODEL NUMBERS OF KNIFE THE SURGEON USED WHEN THE PERFORATION OCCURRED. IT WAS ALSO REPORTED THAT 5 DELAYED BLEEDINGS AND 4 POST-COAGULATION SYNDROMES OCCURRED. IN THE LITERATURE, DELAYED BLEEDING WAS DEFINED AS CLINICAL EVIDENCE OF POST-ESD BLEEDING THAT REQUIRED EMERGENCY COLONOSCOPY. POST-COAGULATION SYNDROME WAS CLINICALLY DIAGNOSED BASED ON THE PRESENCE OF LOCALIZED ABDOMINAL TENDERNESS, HIGH FEVER (> 38.0 °C), LOCALIZED INFLAMMATORY CHANGE AROUND THE ESD SITE REVEALED BY COMPUTED TOMOGRAPHY, AND NO OBVIOUS FINDINGS OF PERFORATION. WE COULD NOT IDENTIFY THE SEVERITIES AND THE OUTCOMES OF THESE COMPLICATIONS. NO MALFUNCTION WAS REPORTED. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE OLYMPUS PRODUCT AND THE OBSERVED ADVERSE EVENT COULD NOT BE DETERMINED. HOWEVER, WE ASSUMED THAT THE PERFORATIONS MIGHT ASSOCIATE WITH ESD. THEREFORE, OMSC WILL SUBMIT 1 MEDICAL DEVICE REPORT (MDR) FOR THE 2 INTRAOPERATIVE PERFORATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301441 SINGLE USE ELECTROSURGICAL KNIFE KNS OLYMPUS MEDICAL SYSTEMS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other