BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGAMAX CLIP APPLIER

    MDR report key: 3974108 · Received August 1, 2014

    Report

    Report Number
    3005075853-2014-05442
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 13, 2014
    Report Date
    July 18, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT ENERGY DEVICE WAS USED? MONOPOLAR HOOK. DID THE SURGEON BRING FORCES TO NEUTRAL BEFORE FIRING THE DEVICE? YES. HOW EXPERIENCED IS THE SURGEON WITH THE LIGAMAX DEVICE? VERY EXPERIENCED. DID THE SURGEON NOTICE ANYTHING UNUSUAL ABOUT THE SHAPE OF THE CLIPS? NO. WAS THE DEVICE FIRED PLASTIC TO PLASTIC? YES. DID THE PROCEDURE DRIVE THE NEED TO APPLY TORQUE? NO. IS THE PATIENT EXPECTED TO HAVE A FULL RECOVERY? THE SURGEON DOESN¿T KNOW DUE TO CHEMOTHERAPY AND DIALYSIS. WERE CLIPS MALFORMED (UNFORMED, HAVE A GAP) ON TISSUE? NO. WERE YOU ABLE TO SEE IF THE CLIP WAS FULLY ADVANCED INTO THE JAWS BEFORE COMPLETING THE STROKE TO FORM THE CLIP? FULLY ADVANCED. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? NO. DID THE PROCEDURE DRIVE THE NEED TO APPLY TORQUE OR TWISTING OF THE DEVICE? NO. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? THE SURGEON DOESN¿T KNOW WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? OUT THE PATIENT FOR CHECKING THE DEVICE BY THE STAFF. WHAT WERE THE PATIENT¿S PRE-EXISTING CONDITIONS? NA. IS THE SURGEON AN EXPERIENCED USER OF THIS PRODUCT? YES. HOW MUCH BLOOD DID THE PATIENT LOST? WAS A TRANSFUSION REQUIRED? 30 CC, NO. WAS THE PATIENT TAKING ANY ANTICOAGULANTS? IF YES, SPECIFY PRESCRIBED MEDICATION. NO. DOES PATIENT HAVE A KNOWN COAGULATION DISORDER? NO. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? IF SO, WHAT? NO. IS THE PATIENT EXPECTED TO HAVE A FULL RECOVERY? THE SURGEON DOESN¿T KNOW. WHAT IS THE PATIENT¿S CURRENT STATUS? CHEMOTHERAPY DUE TO THE TUMOR, DIALYSIS DUE TO RENAL INSUFFICIENCY. DID THE SURGEON OR ANYONE ELSE MENTIONED DIFFICULTIES WITH THE DEVICE DURING THAT SURGERY? NO. THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. UPON CYCLING THE DEVICE, IT WAS NOTED TO BE EMPTY AND LOCKED OUT. THE DEVICE IS DESIGNED TO LOCK OUT WHEN ALL THE CLIPS HAVE BEEN FIRED. DUE TO THE CONDITION OF THE DEVICE, NO. FUNCTIONAL TESTING COULD BE PERFORMED TO EVALUATE THE INCIDENT REPORTED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE EVENT REPORTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    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. THE FOLLOWING INFORMATION HAS BEEN REQUESTED BUT NOT YET OBTAINED: WHAT ENERGY DEVICE WAS USED? DID THE SURGEON BRING FORCES TO NEUTRAL BEFORE FIRING THE DEVICE? HOW EXPERIENCED IS THE SURGEON WITH THE LIGAMAX DEVICE? DID THE SURGEON NOTICE ANYTHING UNUSUAL ABOUT THE SHAPE OF THE CLIPS? WAS THE DEVICE FIRED PLASTIC TO PLASTIC? DID THE PROCEDURE DRIVE THE NEED TO APPLY TORQUE? IS THE PATIENT EXPECTED TO HAVE A FULL RECOVERY?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC ADRENALECTOMY PROCEDURE, THE SURGEON USED THE DEVICE FOR A FEW TIMES AND IT WORKED PROPERLY. THE SURGEON DISSECTED THE ADRENAL ARTERY AND APPLIED TWO CLIPS PROXIMALLY AND ONE CLIP DISTALLY, THEN HE CUT THE ARTERY. THE SURGEON IDENTIFIED BLEEDING. DUE TO THE SMALL SIZE OF THE PATIENT, THE SURGEON DECIDED TO OPEN THE PATIENT. HE CONTROLLED THE BLEEDING WITH AN ENERGY DEVICE AND FINISHED THE PROCEDURE. AFTER CONTROLLING THE BLEEDING, THE SURGEON IDENTIFIED THAT ON THE PATIENT SIDE OF THE RESECTED ARTERY, ONE OF THE CLIPS WAS NOT ON THE ARTERY, AND THE OTHER ONE WAS VERY LOOSE WITH MINIMAL BLEEDING, AND LOOKED LIKE IT WAS NOT FULLY CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450737 LIGAMAX CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1