BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH*XCEL KIL TIP TROC PAK

    MDR report key: 2575954 · Received May 16, 2012

    Report

    Report Number
    3005075853-2012-02323
    Event Type
    Malfunction
    Date Received
    May 16, 2012
    Date of Event
    May 4, 2012
    Report Date
    May 7, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION REQUESTED: WERE ANY NOISES HEARD SUCH AS "WHISTLING" OR "HISSING"? UNK. IF SO, DID THE "NOISE" PREVENT INSUFFLATION? UNK. PLEASE DESCRIBE THE NOISE. WAS THERE A DROP IN PRESSURE? UNK IF YES, DID THIS AFFECT THE VISIBILITY OF THE SURGEON? WHAT WAS THE GAS CONSUMPTION RATE OR VOLUME (LITER/MINUTE)? UNK. WERE YOU ABLE TO IDENTIFY WHERE THE LEAK WAS COMING FROM? UNK. WAS A DEVICE INSERTED IN THE TROCAR DURING THE LEAKING? UNK IF SO, WHAT DEVICE? WAS ANY TORQUE BEING APPLIED TO THE TROCAR OR DEVICE? UNK. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS FUNCTIONALLY TESTED TO DETECT ANY LEAKING ISSUES. UPON EVALUATION OF THE DEVICE, IT WAS FUNCTIONALLY LEAK TESTED AND PASSED. THE DEVICE WAS FULLY FUNCTIONAL ACCORDING TO THE MANUFACTURING REQUIREMENTS. 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.

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TROCAR LEAKED PNEUMO. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH*XCEL KIL TIP TROC PAK LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA H44M87

    Patients

    Seq Age Sex Outcome Treatment
    1