BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ELECTROSURGICAL KNIFE

    MDR report key: 11500405 · Received March 17, 2021

    Report

    Report Number
    8010047-2021-03827
    Event Type
    Injury
    Date Received
    March 17, 2021
    Report Date
    March 17, 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 CORPORATION (OMSC). THE MALFUNCTION OF THE SUBJECT DEVICE CONCERNING THIS CASE HAS NOT BEEN REPORTED. THE EXACT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORPORATION. (OMSC) RECEIVED A LITERATURE TITLED "CLINICAL SIGNIFICANCE OF THE MUSCLE-RETRACTING SIGN DURING COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION". THE LITERATURE REPORTED THE RESULT OF 357 PATIENTS WITH COLORECTAL NEOPLASMS OF ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE USING OLYMPUS KD-630L OR NON-OLYMPUS DEVICE FROM JUNE 2002 TO JUNE 2007. IN THE SUBJECT CASE, 7 CASES OF PERFORATION OCCURRED. OMSC WILL SUBMIT A MEDICAL DEVICE REPORT (MDR) DEPENDING ON THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397051 SINGLE USE ELECTROSURGICAL KNIFE SINGLE USE ELECTROSURGICAL KNIFE KNS OLYMPUS MEDICAL SYSTEMS CORP. KD-630L

    Patients

    Seq Age Sex Outcome Treatment
    1 Other