BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2212792 · Received August 16, 2011

    Report

    Report Number
    3005075853-2011-03324
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 26, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT: ADDITIONAL QUESTIONS FOR THE BROKEN JAW INCIDENT (FIRST DEVICE USED): DID THE JAWS BREAK INSIDE OR OUTSIDE THE PATIENT? WAS THERE ANY TORQUE APPLIED OR TWISTING OF THE DEVICE DURING FIRING? WHAT STRUCTURE WAS THE DEVICE BEING FIRED ACROSS? WHY WAS THE TEAM ATTEMPTING TO RE-INSERT THE DEVICE THROUGH THE TROCAR IF THE JAWS WERE BROKEN? DOES THIS ACCOUNT REPROCESS LIGAMAX? ADDITIONAL QUESTIONS FOR THE OPENING RELATED ISSUE (SECOND DEVICE USED): WHICH FIRING DID THIS OCCUR ON? DID THE SURGEON TRY TO PULL THE TRIGGER FROM THE HANDLE? IS THE SURGEON AWARE THAT THE FIRING TRIGGER MAY NEED ASSISTANCE IN RETURNING ALL THE WAY FORWARD? HOW LONG HAS THE SURGEON BEEN USING LIGAMAX? ARE YOU AWARE OF THE LAST TIME THE SURGEON WAS IN-SERVICED ON LIGAMAX? HOW WAS THE DEVICE REMOVED? HOW WAS THE LIVER REPAIRED? WHAT WAS DONE TO CONTROL THE BLEEDING? HOW MUCH BLOOD WAS LOST? DID THE PATIENT REQUIRE ANY BLOOD PRODUCTS? WHAT DEVICE WAS USED TO COMPLETE THE PROCEDURE? PLEASE SPECIFY WHAT MEDICAL INTERVENTION WAS TAKEN TO PREVENT PERMANENT IMPAIRMENT? WAS THE PROCEDURE COMPLETED WITHOUT FURTHER CONSEQUENCE FOR THE PATIENT? IF NO, PLEASE EXPLAIN. WHAT IS THE PATIENT'S CURRENT STATUS?

    Additional Manufacturer Narrative · 1

    (B)(4). JAWS/CAM. THE ANALYSIS RESULTS OF DEVICE (A) FOUND THAT IT WAS RECEIVED WITH ONE JAW AND CAM RAMP DISENGAGED. THIS CONDITION WOULD NOT ALLOW THE JAWS TO COLLAPSE IN ORDER TO FORM THE CLIPS. 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. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW. THE ANALYSIS RESULTS FOUND THAT DEVICE (B) WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED, AND FORMED THE REMAINING CLIPS AS INTENDED. THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL AND CONFORMING TO OUR MANUFACTURING SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW. BATCH # H91586 (MFG DATE 05/23/2011 EXP DATE 04/23/2016) (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE FIRST DEVICE, WAS FIRED ONCE AND THEN THE TIP BROKE. THE TEAM COULD NOT RE-INSERT IT THROUGH THE 5MM PORT. A SECOND DEVICE WAS OPENED, IT WAS FIRED ONCE AND THE TIP WOULD NOT OPEN, IT WAS STUCK ON A VESSEL ON THE LIVER. AS A RESULT, A CHUNK OF THE LIVER WAS NEARLY TORN OFF AND BLEEDING ISSUES WAS ENCOUNTERED AS A RESULT OF THE DEVICE ISSUES. THE SURGERY WAS PROLONGED TEN MINUTES. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA H43X8R

    Patients

    Seq Age Sex Outcome Treatment
    1