BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1171538 · Received September 18, 2008

    Report

    Report Number
    3005075853-2008-01772
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 27, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 09/18/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SIGMOIDECTOMY PROCEDURE, THE TRIGGER WAS HARD TO GRASP AT THE SECOND FIRING AFTER THE SECOND CLIP WAS FED TO THE JAW. IT WAS GRASPED FORCIBLY, AND THE JAW WOULD NOT OPEN. THE TRIGGER WAS RETURNED WITH BOTH HANDS BY FORCE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER FZP ETHICON ENDO-SURGERY, LLC NA E4KY7L

    Patients

    Seq Age Sex Outcome Treatment
    1