BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER

    MDR report key: 15418735 · Received September 13, 2022

    Report

    Report Number
    MW5112014
    Event Type
    Injury
    Date Received
    September 13, 2022
    Date of Event
    September 8, 2022
    Report Date
    September 9, 2022
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT SCHEDULED FOR LAPAROSCOPIC ROUX-N-Y GASTRIC BYPASS. LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER (COVIDIEN REF #LF1837, LOT #20830176X, EXP 3/23/2027 UTILIZED TO REPLACE FAILED HARMONIC SCALPEL DEVICE. THE ABOVE LIGASURE DEVICE CONNECTED TO COVIDIEN VALLEYLAB FT10 ESU (ASSET # 19961, REF #VLFT10GEN, SN #(B)(4) BY RN WITH NO ALERTS INDICATED ON THE ESU SCREEN. THE SURGEON UTILIZED THE LIGASURE DEVICE, AND NOTED THE DEVICE DID NOT FUNCTION PROPERLY AND CAUSED DAMAGE TO A BLOOD VESSEL THAT WAS IMMEDIATELY ADDRESSED. THE ESU DISPLAY SCREEN THEN DISPLAYED THE FOLLOWING MESSAGE: "INCOMPLETE SEAL CYCLE" "INSPECT SEAL" "PRESS ACTIVATION BUTTON" "E 402 HOLD UNTIL COMPLETE SEAL CYCLE" THE SURGEON DID NOT USE THE LIGASURE DEVICE FURTHER. PATIENT SAFETY MAINTAINED WITH MINIMAL DELAY IN SURGICAL PROCEDURE TO CONTROL BLEEDING. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2621185 LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN 20830176X

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Unknown Required Intervention COVIDIEN VALLEYLAB FT10 ESU