BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2181771 · Received July 27, 2011

    Report

    Report Number
    3005075853-2011-03041
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 13, 2011
    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 OF DEVICE (A) FOUND THAT IT WAS RECEIVED WITH THE SHAFT BENT AT HANDLE ASSEMBLY AREA MAKING THE INSTRUMENT NON-FUNCTIONAL. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. THE ANALYSIS RESULTS OF DEVICE (B) FOUND THAT IT WAS RETURNED EMPTY AND WITH THE LOCK OUT MECHANISM BROKEN AS IT WAS FIRED THROUGH. THE INSTRUMENT IS DESIGNED TO LOCK OUT AFTER ALL THE CLIPS HAVE BEEN FIRED; THEREFORE A POTENTIAL CAUSE OF THE CUSTOMER REPORTED EXPERIENCE IS THE FIRING OF ALL OF THE CLIPS AND THE INSTRUMENT "WOULD NOT FIRE" (ACTIVATION OF THE LOCK OUT MECHANISM). THE INSTRUMENT HAS AN ORANGE INDICATOR THAT APPEARS ON THE TOP OF THE HANDLE AS A REFERENCE FOR THE USER AS TO THE QUANTITY OF CLIPS REMAINING. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. BATCH # H9020C, MFG DATE 01/11/2011; MFG DATE 12/11/2015. (B)(4) LOCKOUT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, ALTHOUGH THE FIRST CLIP COULD BE FIRED PROPERLY, THE CLIP BECAME NOT TO BE FED INTO THE JAW AND COULD NOT BE FIRED FROM SECOND FIRING. THE SAME EVENT OCCURRED IN THE SECOND DEVICE. 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 CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1