BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER

    MDR report key: 4181558 · Received October 17, 2014

    Report

    Report Number
    1717344-2014-00907
    Event Type
    Injury
    Date Received
    October 17, 2014
    Report Date
    October 9, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED LF1637 WAS RECEIVED FOR EVALUATION AND VISUAL INSPECTION FOUND THE PIVOT PIN WAS NOT WELDED AND THE WIRE GUIDE HAD BEEN FORCED DOWN INTO THE SHAFT, BREAKING THE TABS THAT HOLD IT IN PLACE. THE CUSTOMER REPORTED THAT THE DEVICE DOES NOT CLOSE. THE REPORTED CONDITION WAS CONFIRMED. COVIDIEN INVESTIGATION PERSONNEL DETERMINED THAT THE DEVICE WAS NOT FUNCTIONAL BECAUSE THE PIVOT PIN WAS NEVER WELDED AND JAWS WERE NOT HELD IN PLACE. AT SOME POINT THE JAWS WERE PULLED BACK INTO THE SHAFT, DESTROYING THE WIRE GUIDE BY BREAKING OFF THE PLASTIC TABS THAT HOLD IT IN PLACE. THE INVESTIGATION IDENTIFIED THE ROOT CAUSE OF THE REPORTED EVENT TO BE MULTIPLE ASSEMBLY ERRORS. THE IFU WARNS USERS TO INSPECT THE INSTRUMENT AND CORDS FOR BREAKS, CRACKS, NICKS, OR OTHER DAMAGE BEFORE USE. FAILURE TO OBSERVE THIS CAUTION MAY RESULT IN INJURY OR ELECTRICAL SHOCK TO THE PATIENT OR SURGICAL TEAM OR CAUSE DAMAGE TO THE INSTRUMENT. IF DAMAGED, DO NOT USE. MANUFACTURING NON-CONFORMANCES WERE REVIEWED. NO ENTRIES PERTINENT TO THE CUSTOMER'S REPORT WERE NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE JAWS WERE NOT CLOSING PROPERLY DURING THE PROCEDURE. THE DEVICE WAS RETURNED TO COVIDIEN AND VISUAL INSPECTION CONFIRMED THAT THE WIRE GUIDE WAS BROKEN AND THE PLASTIC TABS WERE MISSING FROM THE DEVICE. THERE IS NO INFORMATION FROM THE SITE REGARDING IF THE TABS DID OR DID NOT FALL INTO THE PATIENT CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662172 LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP LF1637 40930200X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other