BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1549111 · Received December 2, 2009

    Report

    Report Number
    3005075853-2009-07313
    Event Type
    Malfunction
    Date Received
    December 2, 2009
    Date of Event
    November 2, 2009
    Report Date
    November 9, 2009
    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

    (B)(4). (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY PROCEDURE, THE DEVICE WAS USED FOR THE CYSTIC DUCT. THE JAW BEGAN NOT TO OPEN AFTER CLIPPING ON THE SECOND OR THE THIRD FIRING. THE JAW WAS OPENED BY RETURNING THE TRIGGER TO ITS HOME POSITION BY HAND. THE CLIPS WERE FORMED PROPERLY. THE DOCTOR COMMENTED THAT HE HAD FELT THE TRIGGER HAD BEEN VERY HARD TO GRASP AT THE FIRST FIRING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE DEVICE WAS FIRED SEVERAL TIMES BY THE NURSE AFTER THE OPERATION TO CHECK IT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1