BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2181893 · Received July 28, 2011

    Report

    Report Number
    3005075853-2011-03047
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 23, 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). INFORMATION WAS NOT PROVIDED BY THE AFFILIATE. THE ANALYSIS RESULTS OF THE DEVICE 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. FURTHER EVALUATION FOUND THAT ONE JAW RAMP WAS BROKEN. ONE POSSIBLE CAUSE FOR THE DAMAGE FOUND MIGHT BE EXCESSIVE LOADING DUE TO FORMING A CLIP OVER ANOTHER CLIP EXCEEDING THE STRUCTURAL CAPABILITY OF THE JAWS. IN ADDITION, ONE JAW WAS NOTED TO BE BROKEN AT BIFURCATION. EVIDENCES OF CORROSION ON THE BROKEN AREA WERE NOTED. THE MOST LIKELY REASON FOR JAW BIFURCATION BREAKAGE IS STRESS CORROSION CRACKING AND THE MOST LIKELY ROOT CAUSE IS EXPOSURE TO A SOLUTION CONTAINING CHLORINE. THIS CONDITION IS VERY UNLIKELY TO OCCUR DURING A SURGICAL PROCEDURE AND IS MOST LIKELY TO OCCUR AFTER POST-SURGERY DEVICE CLEANING. THE JAW BREAKAGE IS NOT OCCURRING AS A RESULT OF THE PRODUCT COMPLAINT DECONTAMINATION PROCESS. PLEASE NOTE THAT THE FOUND CONDITION OF THE JAWS IS UNRELATED WITH THE INCIDENT REPORTED. 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 PROCEDURE, THE CLIP BECAME NOT TO BE FED INTO THE JAW AFTER SEVERAL FIRINGS AND THE DEVICE COULD NOT BE FIRED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES FOR 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