BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP CLIP APPLIER

    MDR report key: 4110847 · Received September 23, 2014

    Report

    Report Number
    3005075853-2014-06620
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 11, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDO
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? - NO. DID THE PROCEDURE DRIVE THE NEED TO APPLY TORQUE OR TWISTING OF THE DEVICE? ¿NO, BUT, TIPS OF THE APPLICATOR DID NOT CLOSE PROPERLY AND THAT¿S WHY CAME CROSSED. WHAT VESSEL WAS THE DEVICE FIRED ON? PLEASE SPECIFY THE SIZE OF THE VESSEL.-THIN VASCULAR VESSEL. HOW WAS "TRAUMA" REPAIRED?- LEAK WAS SUPPORTED BY POLYMER CLIP. WAS THERE ANY CHANGE TO PROCEDURE OR POST-OP PATIENT CARE?- NO. WHAT IS CURRENT PATIENT STATUS?- NORMAL. DID BLEEDING OCCUR? -YES. IF BLEEDING OCCURRED, HOW MUCH BLOOD DID THE PATIENT LOSE? -BLEEDING WAS LIKE A LEAKAGE, SMALL AMOUNT OF BLEEDING OCCURED. WAS A TRANSFUSION REQUIRED (WERE BLOOD PRODUCTS GIVEN)? -THERE WAS NO NEED FOR TRANSFUSION. WAS ANY FURTHER INTERVENTION REQUIRED TO REPAIR THE LEAK? -LEAK WAS SUPPORTED BY POLYMER CLIP. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? - NO. DID THE PROCEDURE DRIVE THE NEED TO APPLY TORQUE OR TWISTING OF THE DEVICE? ¿ NO. BUT, TIPS OF THE APPLICATOR DID NOT CLOSE PROPERLY AND THAT¿S WHY CAME CROSSED. WHAT VESSEL WAS THE DEVICE FIRED ON? PLEASE SPECIFY THE SIZE OF THE VESSEL. - THIN VASCULAR VESSEL. DID SCISSORED CLIPS CAUSE BLEEDING? ¿ YES, VERY FEW AMOUNT. WHAT IS CURRENT PATIENT STATUS? ¿ NORMAL. THE BLEEDING WAS ADDRESSED INTRA-OP AND THE PROCEDURE COMPLETED WITH POLYMER LIGALCIP AND WITH NO FURTHER COMPLICATION. PATIENT¿S POST-OP CARE DID NOT CHANGE. THE ANALYSIS RESULTS FOUND THAT THE LX110 DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON FUNCTIONAL TESTING OF THE DEVICE, THE INSTRUMENT LOADED, RETAINED AND DEPLOYED 6 CLIPS AS INTENDED. THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO OUR MANUFACTURING REQUIREMENTS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH HISTORY RECORDS WERE REVIEWED AND TESTED BY EXTERNAL MANUFACTURING THAT THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THE EQUIPMENT.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. 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. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? DID THE PROCEDURE DRIVE THE NEED TO APPLY TORQUE OR TWISTING OF THE DEVICE? WHAT VESSEL WAS THE DEVICE FIRED ON? PLEASE SPECIFY THE SIZE OF THE VESSEL. HOW WAS "TRAUMA" REPAIRED? WAS THERE ANY CHANGE TO PROCEDURE OR POST-OP PATIENT CARE? WHAT IS CURRENT PATIENT STATUS?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHILE THE LIGACLIP BEING COMPRESSED, IT DID NOT CLOSE PROPERLY AND CAME CROSSED BECAUSE OF THE APPLICATOR. SMALL CLIPS CUT THE VESSEL, DID NOT CLOSE PROPERLY. WHEN THE DOCTOR TOOK AWAY CROSSED CLIPS FROM THE PATIENT, IT CAUSED A LITTLE HARM ON PATIENT LIKE A PEN-NIB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589722 LIGACLIP CLIP APPLIER APPLIER, SURGICAL, CLIP GDO ETHICON ENDO-SURGERY, LLC. NA K4CR1U

    Patients

    Seq Age Sex Outcome Treatment
    1 CLIPS - LT100