BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCEL DILATING TIP TROCAR

    MDR report key: 2221548 · Received August 24, 2011

    Report

    Report Number
    3005075853-2011-03477
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 4, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION: WERE ANY NOISES HEARD SUCH AS "WHISTLING" OR "HISSING"? IF SO, DID THE "NOISE" PREVENT INSUFFLATION? PLEASE DESCRIBE THE NOISE. HISSING . 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)? UNK. WERE YOU ABLE TO IDENTIFY WHERE THE LEAK WAS COMING FROM? YES. WAS A DEVICE INSERTED IN THE TROCAR DURING THE LEAKING? NO IF SO, WHAT DEVICE? WAS ANY TORQUE BEING APPLIED TO THE TROCAR OR DEVICE? NO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE LEAKED CO2 WHEN THE INSTRUMENT WAS REMOVED. THE PROBLEM DID NOT AFFECT THE VISIBILITY OF THE SURGEON. THE SAME DEVICE WAS ABLE TO BE USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XCEL DILATING TIP TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA H43V06

    Patients

    Seq Age Sex Outcome Treatment
    1