BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVIDIEN LIGASURE

    MDR report key: 6979202 · Received October 26, 2017

    Report

    Report Number
    MW5072965
    Event Type
    Injury
    Date Received
    October 26, 2017
    Date of Event
    October 10, 2017
    Report Date
    October 24, 2017
    Manufacturer
    MEDTRONIC/ FORMERLY COVIDIEN
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS PERFORMING A LAPAROSCOPIC SIGMOID COLECTOMY AND USING A LIGASURE BLUNT LF1837 TO DISSECT TISSUE AROUND TO SIGMOID COLON. THE SURGEON FELT THE LF1837 WAS NOT PERFORMING COAGULATION CORRECTLY AS IT WAS PULLING AND CUTTING TISSUE. THE SURGEON CHANGED TO ANOTHER LIGASURE APPARATUS THAT COMPLETED THE CASE WITHOUT ANY FURTHER EVENTS. THERE WAS NO HARM TO THE PATIENT AND NO SIGNIFICANT BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760942 COVIDIEN LIGASURE ELECTROSURGICAL CUTTING AND COAGULATION GEI MEDTRONIC/ FORMERLY COVIDIEN LF1837 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention