BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH XCEL BLUNT TIP TROCAR

    MDR report key: 2991064 · Received March 6, 2013

    Report

    Report Number
    3005075853-2013-01065
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 22, 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 OF THE FOUND THAT THE DEVICE WAS RECEIVED WITH THE DUCKBILL OUT OF POSITION AND PRESENT. ONE POTENTIAL CAUSE FOR THE DAMAGE FOUND MAY BE THE SNAGGING OF AN INSTRUMENT DURING INSERTION. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION: DID ANY PIECE OF THAT REDUCER SEAL COME LOSS AND FALL INTO THE PATIENT? IF SO HOW WAS THE PIECE RETRIEVED? -- NO. DOES THIS TROCAR HAVE THE OPTIVIEW TECHNOLOGY? - NO INFORMATION. WERE ANY NOISES HEARD SUCH AS WHISTLING OR HISSING? - NO INFORMATION. IF SO, DID THE NOISE PREVENT INSUFFLATION? PLEASE DESCRIBE THE NOISE. - NO INFORMATION. WAS THERE A DROP IN PRESSURE? IF YES, DID THIS AFFECT THE VISIBILITY OF THE SURGEON? - NO INFORMATION. WHAT WAS THE GAS CONSUMPTION RATE OR VOLUME (LITER/MINUTE)? - NO INFORMATION. WERE YOU ABLE TO IDENTIFY WHERE THE LEAK WAS COMING FROM? - FROM THE OUTER SEAL. 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? -- NO INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRECTOMY PROCEDURE, REGARDING ONE DEVICE, IT WAS FOUND THAT THE REDUCER SEAL WAS OUT OF ALIGNMENT BEFORE USE. REGARDING ANOTHER DEVICE, 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
    95107 ENDOPATH XCEL BLUNT TIP TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1