BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH XCEL TROCAR

    MDR report key: 2212875 · Received August 16, 2011

    Report

    Report Number
    3005075853-2011-03330
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 22, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION: DID THE NOISE PREVENT INSUFFLATION? ---NO INFORMATION. WAS THERE A DROP IN PRESSURE? IF YES, DID THIS AFFECT THE VISIBILITY OF THE SURGEON? ---NO. WHAT WAS THE GAS CONSUMPTION RATE OR VOLUME (LITER/MINUTE)? ---NO INFORMATION. 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 CHOLECYSTECTOMY PROCEDURE, AIR LEAKED FROM THE VALVE WITH A HISSING NOISE. THE EVENT OCCURRED WHEN A SCOPE WAS REMOVED. WHEN THE SURGEON PUT HIS FINGER INTO AND OUT THE TROCAR SEVERAL TIMES, THE AIR LEAK STOPPED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO DEVICE WILL BE RETURNING.

    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 SCOPE