BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE V 5 MM SEALER DIVIDER

    MDR report key: 991261 · Received February 1, 2008

    Report

    Report Number
    1717344-2008-00038
    Event Type
    Injury
    Date Received
    February 1, 2008
    Date of Event
    January 1, 2007
    Report Date
    November 26, 2007
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS FOUND TO BE MISSING THE JAW HINGE PIN. CORRECTIVE ACTION HAS BEEN TAKEN TO MITIGATE THIS FAILURE MODE. THE INCIDENT DEVICE WAS MANUFACTURED PRIOR TO THE CORRECTIVE ACTION. THE SITE WAS CONTACTED AND ASKED TO FOLLOW-UP WITH THE PT DUE TO THE MISSING JAW HINGE PIN. IF ADD'L INFO IS OBTAINED FROM THE SITE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE REPORT STATED THAT THE JAW OF THE LIGASURE V HANDPIECE WAS DEFECTIVE. THE CUSTOMER REPORTED THAT NOTHING DISENGAGED FROM THE INSTRUMENT AND THAT THE PT WAS NOT INJURED. DURING VISUAL EXAMINATION OF THE INCIDENT DEVICE AT COVIDIEN LP (FORMERLY VALLEYLAB), IT WAS DISCOVERED THAT THE JAW PIN HINGE WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE V 5 MM SEALER DIVIDER LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 108606A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Other