BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH XCEL BLUNT TIP TROCAR

    MDR report key: 2946205 · Received February 6, 2013

    Report

    Report Number
    3005075853-2013-00525
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 17, 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). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD CONDITION. A LEAK TEST WAS PERFORMED AND THE DEVICE WAS NOTED TO LEAK WITHOUT THE TEST PROBE INSERTED THROUGH THE DEVICE. AS EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING THE MANUFACTURING PROCESS, NO CONCLUSION COULD BE REACHED AS TO WHAT MIGHT HAVE CAUSED THE REPORTED EVENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). DOES THIS TROCAR HAVE THE OPTIVIEW TECHNOLOGY? ---NO. WERE ANY NOISES HEARD SUCH AS WHISTLING OR HISSING? ---YES. IF SO, DID THE NOISE PREVENT INSUFFLATION? ---YES PLEASE DESCRIBE THE NOISE. ---NO INFORMATION. WAS THERE A DROP IN PRESSURE? ---NO IF YES, DID THIS AFFECT THE VISIBILITY OF THE SURGEON? ---NO. WHAT WAS THE GAS CONSUMPTION RATE OR VOLUME (LITER/MINUTE)? ---EIGHT TO 10 L/MIN. WERE YOU ABLE TO IDENTIFY WHERE THE LEAK WAS COMING FROM? ---VALVE. WAS A DEVICE INSERTED IN THE TROCAR DURING THE LEAKING? ---YES. IF SO, WHAT DEVICE? ---CAMERA.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51009 ENDOPATH XCEL BLUNT TIP TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1