BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1820175 · Received October 30, 2007

    Report

    Report Number
    1527736-2007-07174
    Event Type
    Malfunction
    Date Received
    October 30, 2007
    Date of Event
    September 12, 2007
    Report Date
    September 14, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC.(CINCINNATI)
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE B12LT WAS RECEIVED WITH THE INNER SEAL OF THE UNIVERSAL SEAL ASSEMBLY DEFORMED. THE INSTRUMENT WAS FUNCTIONALLY TESTED FOR LEAKS AND IT FAILED DUE TO THE INNER SEAL CONDITION. NO CONCLUSION COULD BE REACHED AS TO WHAT MIGHT HAVE CAUSED THE INNER SEAL TO BECOME DEFORMED. 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 HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BLADDER PROCEDURE GAS LEAKED FORM THE DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT. DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE - 12 MM DIAMETER, 100 MM LE GCJ ETHICON ENDO SURGERY, INC.(CINCINNATI) NA D4HE5H

    Patients

    Seq Age Sex Outcome Treatment
    1