BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ELECTROSURGICAL KNIFE KD-650

    MDR report key: 10841987 · Received November 16, 2020

    Report

    Report Number
    8010047-2020-08968
    Event Type
    Injury
    Date Received
    November 16, 2020
    Report Date
    November 16, 2020
    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 NOVEMBER 9, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED LITERATURE TITLED "TECHNICAL FEASIBILITY OF ENDOSCOPIC SUBMUCOSAL DISSECTION FOR LOCAL FAILURE AFTER CHEMORADIOTHERAPY OR RADIOTHERAPY FOR ESOPHAGEAL SQUAMOUS CELL CARCINOMA". THIS STUDY WAS CONDUCTED THE ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) FOR THE ESOPHAGEAL SQUAMOUS CELL CARCINOMA ON 608 PATIENTS TREATED WITH CHEMORADIOTHERAPY BETWEEN (B)(6) 2009 AND (B)(6) 2017. THE ESOPHAGEAL TUMORS WERE RESECTED USING THE SUBJECT DEVICE. IN THE LITERATURE, IT WAS REPORTED THAT 17 CASES OF THE PERFORATION AND 4 CASES OF INCOMPLETE ESD HAVE OCCURRED. 15 OF 17 CASES WERE INTRAOPERATIVE PERFORATION, THE OTHER 2 OF 17 CASES WERE POSTOPERATIVE PERFORATION. 2 OF THE 4 INCOMPLETE ESD WAS SWITCHED TO PHOTODYNAMIC THERAPY WITHOUT INTERVENTION, AND THE REMAINING 2 PATIENTS WERE COMPLETED USING ESD WITH SNARING. BASED ON THE AVAILABLE INFORMATION, DETAILED INFORMATION OF THE SUBJECT DEVICE WAS NOT PROVIDED, AND THERE IS NO DESCRIPTION OF THE RELATIONSHIP BETWEEN THE EVENTS AND THE SUBJECT DEVICE. HOWEVER, OMSC ASSUMES THAT THE 15 CASES OF INTRAOPERATIVE PERFORATION MIGHT BE RELATED TO THE SUBJECT DEVICE SINCE THE SUBJECT DEVICE WAS USED FOR SUBMUCOSAL RESECTION. THERE IS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION. OMSC WILL SUBMIT ONE MEDICAL DEVICE REPORT (MDR) FOR THE EVENT TYPE OF THE INTRAOPERATIVE PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1310545 SINGLE USE ELECTROSURGICAL KNIFE KD-650 SINGLE USE ELECTROSURGICAL KNIFE KNS OLYMPUS MEDICAL SYSTEMS CORP. KD-650Q

    Patients

    Seq Age Sex Outcome Treatment
    1 Other