BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASX BLADELESS TROCAR

    MDR report key: 2050799 · Received April 12, 2011

    Report

    Report Number
    3005075853-2011-01456
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 23, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT DEVICE (A, B, C, F, G) WAS RECEIVED WITH THE CAP SEPARATED FROM THE SLEEVE. EVIDENCES OF WELDING WERE NOTED ON THE CAP-SLEEVE ASSEMBLY AREA. A POTENTIAL CAUSE OF THIS CONDITION IS THE REPEATED USE OF (B)(4) AS A STERILIZATION AGENT. SINGLE-USE TROCARS ARE NOT TO BE REUSED, REPROCESSED OR RE-STERILIZED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. DEVICE B, C, F, G ADDITIONAL INFORMATION: BATCH # D9EH3P, EXPIRATION DATE: 11/2012, MANUFACTURING DATE: 12/2007, (B)(4) SLEEVE. THE ANALYSIS RESULTS FOUND THAT DEVICE (D) WAS RECEIVED WITH THE CAP SEPARATED FROM THE SLEEVE AND WITH THE STOPCOCK VALVE BROKEN AT HOUSING ASSEMBLY AREA. EVIDENCES OF WELDING WERE NOTED ON THE CAP-SLEEVE ASSEMBLY AREA. A POTENTIAL CAUSE OF THIS CONDITION IS THE REPEATED USE OF (B)(4) AS A STERILIZATION AGENT. SINGLE-USE TROCARS ARE NOT TO BE REUSED, REPROCESSED OR RE-STERILIZED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. DEVICE D ADDITIONAL INFORMATION: BATCH # D9EH3P, EXPIRATION DATE: 11/2012, MANUFACTURING DATE: 12/2007, (B)(4) SLEEVE. THE ANALYSIS RESULTS FOUND THAT DEVICE (E) 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. DEVICE E ADDITIONAL INFORMATION: BATCH # D9EG74, EXPIRATION DATE: 11/2012, MANUFACTURING DATE: 12/2007, (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC NEPHRECTOMY PROCEDURE, AFTER THE TROCAR IS INSERTED INTO THE ABDOMEN AND THE PNEUMOPERITONEUM ACHIEVED, THE VALVE OF THE TROCAR COMES OUT WHEN THE OBTURATOR IS TAKEN OUT FROM THE CANNULA OF THE TROCAR WHILE FIXED IN THE ABDOMEN. THIS RESULTS IN THE IMMEDIATE LOSS OF PNEUMOPERITONEUM. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BASX BLADELESS TROCAR GCJ ETHICON ENDO-SURGERY, LLC. NA D4JW7X

    Patients

    Seq Age Sex Outcome Treatment
    1