BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* TROCAR

    MDR report key: 2032836 · Received March 29, 2011

    Report

    Report Number
    3005075853-2011-01251
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 8, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: WERE ANY NOISES HEARD SUCH AS WHISTLING OR HISSING? NO INFORMATION. IF SO, DID THE NOISE PREVENT INSUFFLATION? PLEASE DESCRIBE THE NOISE. N/A. WAS THERE A DROP IN PRESSURE? IF YES, DID THIS AFFECT THE VISIBILITY OF THE SURGEON? YES, BUT THE DEVICE WAS REPLACED WITH ANOTHER ONE SOON, THERE WAS NO PROBLEM. WHAT WAS THE GAS CONSUMPTION RATE OR VOLUME (LITER/MINUTE)? THE FLOW RATE WAS UNK, THE INNER PRESSURE WAS 8L/MIN. WERE YOU ABLE TO IDENTIFY WHERE THE LEAK WAS COMING FROM? VALVE. WAS A DEVICE INSERTED IN THE TROCAR DURING THE LEAKING? IF SO, WHAT DEVICE? A FORCEPS. WAS ANY TORQUE BEING APPLIED TO THE TROCAR OR DEVICE? NO. THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RECEIVED WITH THE OBTURATOR INSERTED THROUGH THE SLEEVE CAUSING THE DEFORMATION OF THE SEAL MECHANISM. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TESTING COULD BE PERFORMED TO EVALUATE 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 LAPAROSCOPIC GASTRECTOMY PROCEDURE, ABDOMINAL AIR LEAKED AFTER ABOUT 30 MINUTES. A 5MM FORCEPS WAS USED WITH THE DEVICE AND THE FORCEPS WAS NOT TAKEN IN AND OUT OF THE DEVICE OFTEN. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. 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 G4U29F

    Patients

    Seq Age Sex Outcome Treatment
    1 FORCEP