BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPT BLADELESS 12X100 STABILITY

    MDR report key: 2991460 · Received March 6, 2013

    Report

    Report Number
    3005075853-2013-01095
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION: DOES THIS TROCAR HAVE THE OPTIVIEW TECHNOLOGY? YES. WERE ANY NOISES HEARD SUCH AS "WHISTLING" OR "HISSING"? YES, HISSING. IF SO, DID THE "NOISE" PREVENT INSUFFLATION? YES. WAS THERE A DROP IN PRESSURE? YES, BETWEEN 7-11. WHAT WAS THE GAS CONSUMPTION RATE OR VOLUME (LITER/MINUTE)? NO.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOR THE INSTRUMENT CONFIRMED THAT IT WAS RETURNED THE OBTURATOR WAS RECEIVED INSERTED THROUGH THE SLEEVE. THE SEAL ON THE UNIVERSAL SEAL WAS FOUND DAMAGE. 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 MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HAND ASSISTED LOW ANTERIOR RESECTION WITH PARTIAL NEPHRECTOMY PROCEDURE, THE TROCAR WAS LEAKING PNEUMO ABOUT AN HOUR AND A HALF INTO THE PROCEDURE. THEY WERE USING AN ETRIO, PSE45A, EC45AL IN AND OUT OF THE TROCAR DURING THE PROCEDURE. THE CASE WAS COMPLETED WITH THE DEVICE. THE SURGEON DID SAY THAT IT WAS DIFFICULT AT TIME TO SEE WHERE HE WAS WORKING DUE TO THE TROCAR LEAKING, BUT HE WAS ALSO DEEP IN THE PELVIS WHEN HE WAS WORKING. THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95826 OPT BLADELESS 12X100 STABILITY LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA J4CV40

    Patients

    Seq Age Sex Outcome Treatment
    1