BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX 5MM

    MDR report key: 3944213 · Received July 18, 2014

    Report

    Report Number
    3005075853-2014-05088
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 2, 2014
    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). JAW, CAM. THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RECEIVED INSERTED THROUGH A B5ST AND WITH ONE JAW AND CAM RAMP DISENGAGED. THIS CONDITION WOULD NOT ALLOW THE JAWS TO COLLAPSE AND REMOVE THE TROCAR AND TO FORM THE CLIPS. NO FURTHER FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. POSSIBLE CAUSES FOR THIS CONDITION MAY BE INADVERTENT FORCE, TWISTING OR PRESSURE BEING PLACED ON THE DEVICE JAWS, USING THE JAWS OF THE DEVICE AS A DISSECTOR/RETRACTOR OR DAMAGE TO THE JAWS WHILE ENTERING THE TROCAR. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE JAWS DID NOT CLOSE AFTER FIRING ON THE CYSTIC ARTERY. THE DEVICE WAS REMOVED FROM THE PATIENT WITH A TROCAR. THERE WAS NO UNEXPECTED RESISTANCE IN GRASPING THE TRIGGER. THERE WAS NO UNEXPECTED NOISE. 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
    422386 LIGAMAX 5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 B5ST