BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ELECTROSURGICAL KNIFE

    MDR report key: 11432090 · Received March 8, 2021

    Report

    Report Number
    8010047-2021-03424
    Event Type
    Injury
    Date Received
    March 8, 2021
    Report Date
    March 8, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    KNS
    UDI-DI
    04953170208546
    PMA / PMN Number
    K092309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    "THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP (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 CORP. (OMSC) RECEIVED A LITERATURE TITLED ""EFFECTIVENESS OF AUTOLOGOUS PLATELET-RICH PLASMA FOR THE HEALING OF ULCERS AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION"". THE LITERATURE REPORTED THE RESULT OF 14 PATIENTS WITH ULCER OF ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE USING OLYMPUS KD-610L FROM MAY 2017 TO NOVEMBER 2017. IN THE SUBJECT CASE, 2 CASES OF MAJOR BLEEDING REQUIRING BLOOD TRANSFUSION OCCURRED. OMSC WILL SUBMIT A MEDICAL DEVICE REPORT (MDR) DEPENDING ON THE EVENT TYPE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334723 SINGLE USE ELECTROSURGICAL KNIFE SINGLE USE ELECTROSURGICAL KNIFE KNS OLYMPUS MEDICAL SYSTEMS CORP. KD-610L 04953170208546

    Patients

    Seq Age Sex Outcome Treatment
    1 Other