BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH XCEL TROCAR

    MDR report key: 2222949 · Received August 25, 2011

    Report

    Report Number
    3005075853-2011-03513
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Report Date
    August 9, 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, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION: WERE ANY NOISES HEARD SUCH AS ¿WHISTLING¿ OR ¿HISSING¿? ASKU. IF SO, DID THE ¿NOISE¿ PREVENT INSUFFLATION? YES. PLEASE DESCRIBE THE NOISE. WAS THERE A DROP IN PRESSURE? ASKU. IF YES, DID THIS AFFECT THE VISIBILITY OF THE SURGEON? YES. WHAT WAS THE GAS CONSUMPTION RATE OR VOLUME (LITER/MINUTE)? ASKU. WERE YOU ABLE TO IDENTIFY WHERE THE LEAK WAS COMING FROM? SEAL. WAS A DEVICE INSERTED IN THE TROCAR DURING THE LEAKING? YES. IF SO, WHAT DEVICE? CAMERA. WAS ANY TORQUE BEING APPLIED TO THE TROCAR OR DEVICE? ASKU.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE TROCAR WAS LEAKING PNUEMO. THE LOSS OF PNUEMO AFFECTED THE VISION OF THE SURGEON. THE TROCAR DEVICE THAT WAS USED WAS OUT OF A KIT. ANOTHER DEVICE WAS PULLED TO COMPLETE THE CASE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE DEVICE WAS DISCARDED.

    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