BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* TROCAR

    MDR report key: 2191646 · Received August 4, 2011

    Report

    Report Number
    3005075853-2011-03194
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 27, 2011
    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
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: WERE ANY NOISES HEARD SUCH AS WHISTLING OR HISSING? WHISTLING. IF SO, DID THE NOISE PREVENT INSUFFLATION? PLEASE DESCRIBE THE NOISE. YES, IT INSUFFLATED GAS. WAS THERE A DROP IN PRESSURE? IF YES, DID THIS AFFECT THE VISIBILITY OF THE SURGEON? THERE WAS NO DROP OF PRESSURE. WHAT WAS THE GAS CONSUMPTION RATE OR VOLUME (LITER/MINUTE)? NOT IDENTIFIED. WERE YOU ABLE TO IDENTIFY WHERE THE LEAK WAS COMING FROM? FROM THE UNIVERSAL SEAL. WAS A DEVICE INSERTED IN THE TROCAR DURING THE LEAKING? YES IF SO, WHAT DEVICE? NOT IDENTIFIED. WAS ANY TORQUE BEING APPLIED TO THE TROCAR OR DEVICE? NO. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED WITH THE SEAL MECHANISM OF THE UNIVERSAL SEAL ASSEMBLY DEFORMED. HOWEVER, IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THIS CONDITION. FURTHERMORE, 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. 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. HOWEVER, AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE POTENTIAL ROOT CAUSE OF THE INSUFFLATIONS ISSUES. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL DEVICE RECEIVED FOR ANALYSIS (B)(4) 2011. ADDITIONAL INFORMATION: THE ANALYSIS RESULTS FOUND THAT THE DEVICE (B) WAS RECEIVED IN A GOOD PHYSICAL CONDITION. UPON EVALUATION OF THE DEVICE, THE DUCKBILL WAS FOUND TO BE SLIGHTLY OPEN AT THE SLIT. A LEAK TEST WAS PERFORMED AND THE DEVICE WAS NOTED TO LEAK WITHOUT  THE TEST PROBE INSERTED THROUGH THE DEVICE. 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. HOWEVER, AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE POTENTIAL ROOT CAUSE OF THE INSUFFLATIONS ISSUES. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS. DEVICE B ADDITIONAL INFORMATION: BATCH # H90P60 EXPIRATION DATE: 02/2016 MANUFACTURING DATE: 03/2011.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPY-ASSISTED DISTAL GASTRECTOMY PROCEDURE, THE SURGEON COMPLAINED CONTINUOUS GAS LEAKAGE DURING OPERATIONS. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1