BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH XCEL

    MDR report key: 3252012 · Received July 29, 2013

    Report

    Report Number
    3005075853-2013-03780
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 3, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS THIS A ROBOTIC HYSTERECTOMY? NO. WERE ANY NOISES HEARD SUCH AS ¿WHISTLING¿ OR ¿HISSING¿? IF SO, DID THE ¿NOISE¿ PREVENT INSUFFLATION? PLEASE DESCRIBE THE NOISE. HISSING, YES, NO INSUFFLATION. HOW LONG INTO THE PROCEDURE DID THE TROCARS BEGIN TO LEAK? IMMEDIATELY. WAS THERE A DROP IN PRESSURE? IF YES, DID THIS AFFECT THE VISIBILITY OF THE SURGEON? YES, TO BOTH. WHAT WAS THE GAS CONSUMPTION RATE OR VOLUME (LITER/MINUTE)? UNKNOWN. WHAT TYPE OF INSUFFLATOR OR PRESSURE WAS BEING USED? STRYKER. WERE THERE ANY DEVICES BEING INSERTED IN THE TROCARS? IF SO, WHAT DEVICES? LAPARASCOPE, 5MM GRASPER. WAS ANY TORQUE BEING APPLIED TO THE TROCAR OR DEVICE? NO. WAS THE SURGEON ABLE TO IDENTIFY WHERE THE LEAKING WAS COMING FROM? TOP OF SEAL. WAS THE LEAKING CONSTANT OR INTERMITTENT? UNKNOWN. HOW MANY PORTS WERE PLACED? FOUR (4). WHAT PORT WAS THE C02 HOOKED UP TO? UNKNOWN. WERE ALL FIVE TROCARS USED DURING THE PROCEDURE? YES. PLEASE CLARIFY HOW MANY OF THE D5LT TROCARS LEAKED? TWO (2). PLEASE CLARIFY HOW MANY OF THE CB5LT TROCARS LEAKED? SIX (6). WAS THERE A SPECIFIC TROCAR THAT CAUSED THE CONVERSION? ALL. WERE THERE ANY OTHER FACTORS THAT LED TO THE CONVERSION? UNKNOWN. WAS THE PATIENT¿S POST OP CARE ALTERED DUE TO THE CONVERSION? IF SO, PLEASE PROVIDE DETAILS OF POST OP CARE. UNKNOWN. WAS THE PATIENT OBESE? WHAT IS THE PATIENT¿S BMI? NO. PATIENT'S CURRENT STATUS? STABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). LEAK FAILURE. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN A GOOD PHYSICAL CONDITION. UPON EVALUATION OF THE DEVICE, THE DUCKBILL WAS FOUND TO BE SLIGHTLY OPEN AT SLIT. A LEAK TEST WAS PERFORMED AND THE DEVICE WAS NOTED TO LEAK WITHOUT THE TEST PROBE INSERTED THROUGH THE DEVICE. A POTENTIAL CAUSE OF THIS FAILURE IS ATTRIBUTED TO MOLDING, COMPONENT TRANSIT, BODILY FLUIDS OR DEBRIS FROM SURGERY. AS EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING THE MANUFACTURING PROCESS, NO CONCLUSION COULD BE REACHED AS TO WHAT MIGHT HAVE CAUSED THE REPORTED EVENT. 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 TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE TROCARS WERE REPORTED TO BE LEAKING. ONE CAMERA PORT AND TWO SLEEVES. THE DOCTOR NOTED THAT LEAKING OCCURRED ON INITIAL ENTRY AND CONTINUED TO LEAK. REPLACED ALL THREE TROCARS TWICE. THE CASE WAS CONVERTED TO A VAGINAL APPROACH. COULD NOT MAINTAIN PNEUMO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352790 ENDOPATH XCEL LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention