BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* BLADELESS TROCAR

    MDR report key: 2771923 · Received October 4, 2012

    Report

    Report Number
    3005075853-2012-04532
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 1, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE (A) WAS RETURNED IN GOOD 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 ANALYSIS RESULTS FOUND THAT THE DEVICE (B) WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS FUNCTIONALLY TESTED TO DETECT ANY LEAKING ISSUES. A LEAK TEST WAS PERFORMED AND THE DEVICE WAS NOTED TO LEAK DURING INSERTION AND REMOVAL OF THE TEST PROBE THROUGH THE DEVICE. IT SHOULD BE NOTED THAT AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE POTENTIAL ROOT CAUSE OF THE REPORTED INSUFFLATIONS ISSUES. THE FINAL QUALITY RELEASE CRITERIA WERE MET BEFORE THIS BATCH WAS RELEASED FOR DISTRIBUTION. DEVICE B ADDITIONAL INFORMATION: BATCH # G9L220, EXPIRATION DATE: 08/2015, MANUFACTURING DATE: 09/2010.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION: WERE ANY NOISES HEARD SUCH AS WHISTLING OR HISSING?---YES. IF SO, DID THE NOISE PREVENT INSUFFLATION? ---YES. WAS THERE A DROP IN PRESSURE? ---NO. IF YES, DID THIS AFFECT THE VISIBILITY OF THE SURGEON? WHAT WAS THE GAS CONSUMPTION RATE OR VOLUME (LITER/MINUTE)? ---NO INFORMATION. WERE YOU ABLE TO IDENTIFY WHERE THE LEAK WAS COMING FROM? ---OUTER SEAL WAS A DEVICE INSERTED IN THE TROCAR DURING THE LEAKING? ---NO INFORMATION. IF SO, WHAT DEVICE? WAS ANY TORQUE BEING APPLIED TO THE TROCAR OR DEVICE? ---NO INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC PANCREAS REMOVAL PROCEDURE, AIR LEAKED FROM THE OUTER SEAL. ALTHOUGH THE OUTER SEAL WAS REPLACE WITH THE 2ND ONE, AIR KEPT LEAKING. THE SAME DEVICE WAS USED AS IS TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** XCEL* BLADELESS TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA G4TX9A

    Patients

    Seq Age Sex Outcome Treatment
    1