BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE

    MDR report key: 12008587 · Received June 16, 2021

    Report

    Report Number
    3006451981-2021-00077
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Date of Event
    May 25, 2021
    Report Date
    June 16, 2021
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT SOLD IN US AND IS 510(K) EXEMPT. THIS REPORT IS ASSOCIATED TO A SIMILAR PRODUCT SOLD IN THE US WITH 510(K) NUMBER K102470. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, ABOUT 1 HOUR AFTER STARTING THE OPERATION, THE OPENING PART OF THE JAWS BECAME BAD, SO THE AREA OF THE JAWS WAS WIPED, BUT IT BECAME HARDER TO OPEN THAN USUAL. THE JAW WAS PARTIALLY OPEN. THERE WERE NO PROBLEMS WITH SEALING OR CUTTING, BUT THE CUT TRIGGER FELT HEAVIER THAN USUAL. (NO RECHARGE ALARM, ETC.) ANOTHER DEVICE WAS TAKEN OUT AND THE OPERATION WAS COMPLETED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902833 LIGASURE ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MEDICAL PRODUCTS LF1212 S1AH718PX

    Patients

    Seq Age Sex Outcome Treatment
    1