BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCEL DILATING TIP TROCAR 11MM

    MDR report key: 1172480 · Received September 22, 2008

    Report

    Report Number
    3005075853-2008-01844
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Date of Event
    August 28, 2008
    Report Date
    September 1, 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
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WELD. EVALUATION SUMMARY - THE ANALYSIS RESULTS FOUND THAT THE D11LT 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. THE ENERGY DIRECTORS HAVE EVIDENCE OF NOT BEING PROPERLY WELDED DURING THE MANUFACTURING PROCESS. 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. AS THE OBTURATOR WAS NOT RECEIVED FOR ANALYSIS WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES.

    Description of Event or Problem · 1

    IT WAS REPORTED PRIOR TO A LAPAROSCOPY PROCEDURE, THE DEVICE FELL APART WHEN REMOVED FROM PACKAGING. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XCEL DILATING TIP TROCAR 11MM GCJ ETHICON ENDO-SURGERY, LLC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1