BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE - 12 MM DIAMETER, 100 MM

    MDR report key: 1083031 · Received July 23, 2008

    Report

    Report Number
    3005075853-2008-00632
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    May 13, 2008
    Report Date
    June 3, 2008
    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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CLEAR LENS. EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE B12LTH INSTRUMENT WAS RECEIVED WITH THE UNIVERSAL REDUCER CAP MISASSEMBLED; THEREFORE, THE SEAL CAP AND THE SEAL BASE ARE SEPARATED AND THE INNER SEAL ASSEMBLY OUT OF POSITION; THUS LEADING TO THE REPORTED LEAK ISSUE. THE ENERGY DIRECTORS HAVE EVIDENCE OF NOT BEING PROPERLY WELDED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, THE LENS OF THE OBTURATOR WAS NOTED TO BE CRACKED. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. 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 LAP GASTRIC BYPASS SURGERY THERE WERE 5 TROCARS USED THAT LEAKED DURING THE CASE. THEY WERE SEPARATED FROM WHERE THE HOUSING IS ATTACHED TO THE CANNULA. THEY WERE ABLE TO COMPLETE THE CASE WITH THE 5TH TROCAR WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE - 12 MM DIAMETER, 100 MM GCJ ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1