BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ELECTROSURGICAL KNIFE KD-650

    MDR report key: 11184205 · Received January 18, 2021

    Report

    Report Number
    8010047-2021-01545
    Event Type
    Injury
    Date Received
    January 18, 2021
    Report Date
    January 18, 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

    ON (B)(6) 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE TITLED "LONG-TERM OUTCOMES OF COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION IN ELDERLY PATIENTS". THIS STUDY WAS CONDUCTED THE COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) FOR 482 PATIENTS BETWEEN (B)(6) 2005 TO (B)(6) 2013. IN THE LITERATURE, IT WAS REPORTED THAT 30 PATIENTS OF INTRAOPERATIVE PERFORATIONS INCLUDING A PATIENT WHO REQUIRED EMERGENCY SURGERY, ONE DELAYED PERFORATION, ONE INTRAOPERATIVE BLEEDING WHO REQUIRED EMERGENCY SURGERY, 8 PATIENTS OF POSTOPERATIVE BLEEDINGS. AND 18 PATIENTS WERE DEAD DURING THE FOLLOW-UP PERIOD. BASED ON THE AVAILABLE INFORMATION, THE DELAYED PERFORATION AND THE POSTOPERATIVE BLEEDING WERE NOT REPORTED IN A DIRECT RELATIONSHIP WITH THE OLYMPUS PRODUCTS. AND, REPORTED DEATHS WERE THE CAUSE OF PATIENT DISEASES. THEREFORE, IT WAS NO RELATIONSHIP BETWEEN THE EVENT AND THE SUBJECT DEVICE. HOWEVER, OMSC ASSUMES THAT THE INTRAOPERATIVE PERFORATION AND THE INTRAOPERATIVE BLEEDING MIGHT BE RELATED TO THE SUBJECT DEVICE SINCE THE SUBJECT DEVICE WAS USED FOR ESD. BASED ON THE AVAILABLE INFORMATION, DETAILED INFORMATION ON THE SUBJECT DEVICE WAS NOT PROVIDED. THERE IS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION. OMSC WILL SUBMIT TWO MEDICAL DEVICE REPORTS (MDR) OF THE ELECTROSURGICAL KNIFE FOR THE INTRAOPERATIVE PERFORATION AND THE INTRAOPERATIVE BLEEDING. THIS IS A REPORT REGARDING INTRAOPERATIVE PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82909 SINGLE USE ELECTROSURGICAL KNIFE KD-650 SINGLE USE ELECTROSURGICAL KNIFE KNS OLYMPUS MEDICAL SYSTEMS CORP. KD-650Q

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention