BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK LIGASURE INSTRUMENT

    MDR report key: 3032169 · Received March 7, 2013

    Report

    Report Number
    1717344-2013-00170
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    September 26, 2012
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT SAMPLE WAS NOT RETURNED TO THE QUALITY ASSURANCE LABORATORY FOR ANALYSIS. BECAUSE NO INCIDENT SAMPLE WAS RETURNED, IT CANNOT BE DETERMINED WHERE THE REPORTED DEFECT MIGHT HAVE OCCURRED. WITHOUT A VALID LOT/SERIAL NUMBER, A DETAILED INVESTIGATION COULD NOT BE PERFORMED. THE FILE WILL BE CLOSED AS UNCONFIRMED AT THIS TIME. IF ADD'L INFO IS OBTAINED, OR THE SAMPLE IS RETURNED, WE WILL RE-OPEN THIS INVESTIGATION. THE GENERATOR WAS RETURNED AND THE VISUAL INSPECTION FOUND NO NOTABLE CONDITIONS. THE INVESTIGATION OF THE RETURNED EQUIPMENT DID NOT IDENTIFY ANYTHING THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT OF NO PROPER FUSION. THE GENERATOR WAS TESTED AND FOUND TO FUNCTION NORMALLY AND WITHIN SPECIFICATIONS. THE GENERATORS OUTPUTS WERE CYCLED FOR FOUR HOURS AND NO ANOMALIES WERE NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS NO PROPER FUSION FROM THE DEVICE. NO ILL EFFECT TO THE PT REPORTED, THOUGH THERE WAS SOME BLEEDING. ADD'L QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF THE SAMPLE IS REC'D OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98344 UNK LIGASURE INSTRUMENT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK