BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 3182369 · Received June 21, 2013

    Report

    Report Number
    3005075853-2013-03194
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 14, 2013
    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). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED WITH THE JAW BROKEN. THIS CONDITION WOULD NOT ALLOW THE JAWS TO COLLAPSE IN ORDER TO FORM THE CLIPS. DUE TO THE RETURNED CONDITION OF THE DEVICE NO FUNCTIONAL TEST COULD BE PERFORMED TO EVALUATE THE REPORTED INCIDENT. ALTHOUGH THE RETURNED CONDITION OF THE DEVICE PREVENTED FUNCTIONAL TESTING TO EVALUATE THE REPORTED INCIDENT, THE LOCKOUT MECHANISM WAS IN A CONDITION THAT PERMITTED FURTHER EVALUATION. DURING THIS TESTING, THE DEVICE LOCKED OUT AS INTENDED. HOWEVER, THE ORANGE INDICATOR DID NOT SHOW UP. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ,ADDITIONAL INFORMATION: WAS THE JAW OF THE DEVICE FOUND? ---NO. ONE SIDE OF THE CAM, WHICH IS PROXIMAL PART OF THE JAWS, WAS BROKEN AND MISSING. HOWEVER, WHILE USING THE DEVICE FOR THE PATIENT, THERE WAS NO ABNORMALITY IN APPEARANCE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, TWO CLIPS SOMETIMES CAME OUT AT ONE TIME, AND SCISSORING SOMETIMES OCCURRED FROM THE 2ND FIRING. THE 1ST FIRING WAS COMPLETED WITHOUT ANY DIFFICULTIES. AN UNEXPECTED NOISE WAS HEARD WHILE FIRING. WHEN A CLIP FELL INTO THE PATIENT, IT WAS RETRIEVED WITH A FORCEPS VIA A TROCAR EACH TIME. THE DEVICE WAS USED ON THE CYSTIC ARTERY. IN THE END, THE DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. AS THE INDICATOR SHOWED UP, A NURSE FIRED THE DEVICE OUT OF THE PATIENT. AT THE TIME, A BREAKING NOISE WAS HEARD AND THE JAWS BECAME IN CLOSING. WHEN THE JAWS WERE OPENED BY PULLING THE TRIGGER FROM THE HANDLE, IT WAS FOUND THAT A PROXIMAL PART OF THE JAWS WAS MISSING. THE MISSING PART WAS NOT FOUND ON A MAYO TABLE, IN THE OPERATING ROOM OR ON THE PATIENT¿S BODY SURFACE. IT WAS UNKNOWN WHEN THE JAWS BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282091 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA K4C69H

    Patients

    Seq Age Sex Outcome Treatment
    1