BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH* OPT BLADELESS

    MDR report key: 2232385 · Received September 2, 2011

    Report

    Report Number
    3005075853-2011-03633
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 19, 2011
    Report Date
    August 24, 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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.ADDITIONAL INFORMATION:WAS THERE A DROP IN PRESSURE? YES IF YES, DID THIS AFFECT THE VISIBILITY OF THE SURGEON? NO.WHAT WAS THE GAS CONSUMPTION RATE OR VOLUME (LITER/MINUTE)? UNK.WERE YOU ABLE TO IDENTIFY WHERE THE LEAK WAS COMING FROM? YES.WAS A DEVICE INSERTED IN THE TROCAR DURING THE LEAKING? NO IF SO, WHAT DEVICE? STOPPED WITH DEVICE INSERTED THROUGH TROCAR.WAS ANY TORQUE BEING APPLIED TO THE TROCAR OR DEVICE? NO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A LAPAROSCOPIC SIGMOID COLON RESECTION. THE FIRST TROCAR INSERTED, HOOKED UP PNUEMO AND THE AIR WAS LEAKING FROM THE TOP. THEY PLACED FINGERS OVER THE TROCAR TO STOP THE LEAKING DURING TIME OTHER TROCARS WERE INSERTED. AFTER DEVICE INSERTED INTO THE TROCAR IT STOPPED LEAKING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH* OPT BLADELESS LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA H43K0G

    Patients

    Seq Age Sex Outcome Treatment
    1