BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE V SEALER/DIVIDER

    MDR report key: 3772369 · Received February 18, 2014

    Report

    Report Number
    3006451981-2014-00301
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Report Date
    July 25, 2011
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL INSPECTION OF THE INCIDENT DEVICE REVEALED THAT THE TIP OF THE JAWS WAS BENT AND THE OVER-MOLD WAS CRACKED. THE SEAL PLATE WAS SEPARATED FROM THE MOVING JAW BUT STILL ATTACHED. NO PIECES OF THE JAW WERE MISSING. THE REPORTER EVENT IS MOST LIKELY ATTRIBUTED TO THE USER PLACING EXCESSIVE FORCE ON THE TIP OF THE JAWS CAUSING IT TO BEND AND BREAK.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PORTION OF THE DEVICE JAW BROKE DURING THE PROCEDURE AND FELL INTO THE PATIENT CAVITY. THE PIECE WAS RETRIEVED AND ANOTHER DEVICE WAS USED TO COMPLETE WITHOUT INCIDENT. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103015 LIGASURE V SEALER/DIVIDER LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S0GB010P

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK