BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGICUT

    MDR report key: 9699339 · Received February 12, 2020

    Report

    Report Number
    9680952-2020-00009
    Event Type
    Injury
    Date Received
    February 12, 2020
    Date of Event
    January 16, 2020
    Report Date
    January 21, 2020
    Manufacturer
    SURGICAL INNOVATIONS LTD
    Product Code
    GEI
    PMA / PMN Number
    K063485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION REPORT TO BE ATTACHED ONCE AVAILABLE.

    Description of Event or Problem · 0

    LOGICUT CAUSING BURNS TO PATIENTS.

    Additional Manufacturer Narrative · 1

    INVESTIGATION REPORT TO BE ATTACHED ONCE AVAILABLE.

    Description of Event or Problem · 1

    LOGICUT CAUSING BURNS TO PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161492 LOGICUT LOGICUT SISSORS GEI SURGICAL INNOVATIONS LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other