BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH XCEL BLUNT TIP TROCAR

    MDR report key: 3161604 · Received June 11, 2013

    Report

    Report Number
    3005075853-2013-02916
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 15, 2013
    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). DEVICE WAS NOT RETURNED FOR EVALUATION. DOES THIS TROCAR HAVE THE OPTIVIEW TECHNOLOGY? ---THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. WERE ANY NOISES HEARD SUCH AS WHISTLING OR HISSING? ---THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. IF SO, DID THE NOISE PREVENT INSUFFLATION? PLEASE DESCRIBE THE NOISE. ---THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. WAS THERE A DROP IN PRESSURE? IF YES, DID THIS AFFECT THE VISIBILITY OF THE SURGEON? ---THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. WHAT WAS THE GAS CONSUMPTION RATE OR VOLUME (LITER/MINUTE)? ---THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. WERE YOU ABLE TO IDENTIFY WHERE THE LEAK WAS COMING FROM? ---FROM THE VALVE. WAS A DEVICE INSERTED IN THE TROCAR DURING THE LEAKING? IF SO, WHAT DEVICE? ---NO. WAS ANY TORQUE BEING APPLIED TO THE TROCAR OR DEVICE? ---THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTEROMYOMA PROCEDURE, AIR LEAKED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261933 ENDOPATH XCEL BLUNT TIP TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1