BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE

    MDR report key: 7891139 · Received September 19, 2018

    Report

    Report Number
    3006451981-2018-00599
    Event Type
    Malfunction
    Date Received
    September 19, 2018
    Date of Event
    August 29, 2018
    Report Date
    November 13, 2018
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS
    Product Code
    GEI
    UDI-DI
    30884524000279
    PMA / PMN Number
    K031011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ONE DEVICE WAS RECEIVED FOR EVALUATION. THE RETURNED PRODUCT DID NOT MEET SPECIFICATION AS RECEIVED. VISUAL INSPECTION FOUND THE JAW WAS RETURNED OPEN. FURTHER INVESTIGATION ALSO FOUND THE HANDLE LATCH MECHANISM WAS BROKEN. THE DEVICE WAS DISASSEMBLED AND INVESTIGATION FOUND THAT THE SKI GUIDE TAB WAS BROKEN INSIDE THE INSTRUMENT BODY, MAKING IT IMPOSSIBLE TO LATCH OR UNLATCH THE HANDLE. THIS DAMAGE MADE IT IMPOSSIBLE TO CLOSE THE DEVICE JAWS FOR TISSUE SEALING. THIS KIND OF DAMAGE IS SIMILAR TO WHAT IS SEEN WHEN THE USER FORCES THE LATCH OPEN WHEN THE LATCH BECOMES UNRESPONSIVE DUE TO THE DEVICE BEING LEFT LATCHED FOR AN EXTENDED PERIOD OF TIME. THE INVESTIGATION IDENTIFIED THE ROOT CAUSE OF THE REPORTED EVENT TO BE USER ERROR. THE USER IS ADVISED TO NOT LEAVE THE HANDLE LATCHED WHEN THE DEVICE IS NOT IN USE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    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 LAPAROSCOPY, THE INSTRUMENT JAWS WERE STUCK. THE SURGEON COULD NOT OPEN THEM. AFTER NUMEROUS ATTEMPTS, THE SURGEON REJECTED IT AND CONTINUED WITH ANOTHER DEVICE, WHICH PERFORMED WELL. THERE WAS NO PATIENT INJURY. NO RE-OPERATION NECESSARY AND NO BLOOD LOSS MORE THAN 500 CC. ALSO, THERE WAS NO UNANTICIPATED TISSUE LOSS OR IRREVERSIBLE DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731355 LIGASURE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MEDICAL PRODUCTS LS1500 S8AB018X 30884524000279

    Patients

    Seq Age Sex Outcome Treatment
    1