BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPT BLADELESS 5X100 STABILITY

    MDR report key: 3173388 · Received June 17, 2013

    Report

    Report Number
    3005075853-2013-03077
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 31, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DOES THIS TROCAR HAVE THE OPTIVIEW TECHNOLOGY? YES. WERE ANY NOISES HEARD SUCH AS WHISTLING OR HISSING? YES. IF SO, DID THE NOISE PREVENT INSUFFLATION? NO. WAS THERE A DROP IN PRESSURE? UNKNOWN. IF YES, DID THIS AFFECT THE VISIBILITY OF THE SURGEON? NO. WHAT WAS THE GAS CONSUMPTION RATE OR VOLUME? UNKNOWN. WAS A DEVICE INSERTED IN THE TROCAR DURING THE LEAKING? NO. WHAT WAS THE PRODUCT CODE INSERTED IN THE TROCAR? NA. WAS ANY TORQUE BEING APPLIED TO THE TROCAR OR DEVICE? NO. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS FUNCTIONALLY TESTED TO DETECT ANY LEAKING ISSUES. UPON EVALUATION OF THE DEVICE, IT WAS FUNCTIONALLY LEAK TESTED AND PASSED. THE DEVICE WAS FULLY FUNCTIONAL ACCORDING TO THE MANUFACTURING REQUIREMENTS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TROCAR LEAKED THROUGH THE SEAL. CASE COMPLETED WITH SAME DEVICE. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273899 OPT BLADELESS 5X100 STABILITY LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA K4CE74

    Patients

    Seq Age Sex Outcome Treatment
    1