BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCA MED APPLIER

    MDR report key: 2220407 · Received August 23, 2011

    Report

    Report Number
    3005075853-2011-03461
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 4, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDO
    PMA / PMN Number
    K820837
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. THE FOLLOWING INFORMATION HAS BEEN REQUESTED. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT: WHICH FIRING DID THIS OCCUR ON? DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? WAS THE CLIP FULLY ADVANCED INTO THE JAWS? 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? WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? SINCE THERE WAS BLEEDING, IS IT POSSIBLE THAT THE PATIENT'S HEALTH HISTORY OR ANATOMY CONTRIBUTED TO THE DIFFICULTIES THAT WERE ENCOUNTERED? HOW MUCH BLOOD DID THE PATIENT LOST? WAS A TRANSFUSION REQUIRED? WHAT WAS THE QUALITY OF TISSUE IN THE AREA WHERE THE DEVICE WAS FIRED? I PRESUME THE PATIENT¿S PRE-OP DIAGNOSIS WAS CANCER, PLEASE CONFIRM. IF APPLICABLE, DOES THE PATIENT HAVE A HISTORY OF RECEIVING RADIATION OR CHEMOTHERAPY OR A RELEVANT HISTORY OF SURGICAL TREATMENTS? IF SO, WHAT? WHAT IS THE AGE AND SEX OF THE PATIENT? WHAT IS THE CURRENT STATUS OF THE PATIENT? WAS THE ONLY REASON FOR THE DELAY IN THE PROCEDURE THE DIFFICULTIES WITH THE DEVICE WHICH CAUSES THE BLEEDING OR WHERE THERE OTHER CIRCUMSTANCES WHICH CAUSED THE DELAY? WAS THERE A RECENT CONVERSION TO EES DEVICES IN THIS ACCOUNT OR WITH THIS SURGEON?

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHICH FIRING DID THIS OCCUR ON? 3 OR 4. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? NO. WAS THE CLIP FULLY ADVANCED INTO THE JAWS? YES. DID THE PROCEDURE DRIVE THE NEED TO APPLY TORQUE OR TWISTING OF THE DEVICE? YES. WHAT VESSEL WAS THE DEVICE FIRED ON? PLEASE SPECIFY THE SIZE OF THE VESSEL? VERY SMALL SIZE. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? NO. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? NO INFO. WHAT WERE THE PATIENT'S PRE-EXISTING CONDITIONS? NO INFO. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? IF SO, WHAT? NO INFO. WAS THERE A RECENT CONVERSION TO EES DEVICES IN THIS ACCOUNT OR WITH THIS SURGEON? NO INFO. THE ANALYSIS RESULTS FOUND THAT DEVICE A 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. 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. 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 MASTECTOMY PROCEDURE, WHEN THE SURGEON CLOSED THE DEVICE DOWN TO APPLY CLIPS, THERE WERE A SERIES OF CLIPS THAT DID NOT DEPLOY. ALSO, WHEN ONE OF THE CLIPS DID DEPLOY, THE CLIP CAUSED THE VESSEL TO BE CUT AND LED TO A SERIOUS BLEED WHICH REQUIRED SUTURING AND A 40 MINUTE DELAY IN THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCA MED APPLIER CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1