BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DILATING TIP TROCAR WITH STABILITY SLEEVE - 12 MM DIAMETER

    MDR report key: 1210052 · Received October 22, 2008

    Report

    Report Number
    1527736-2008-03980
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Report Date
    September 29, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GCJ
    PMA / PMN Number
    K952842
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DETACHED STOPCOCK. EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE INSTRUMENT WAS RECEIVED WITH THE STOPCOCK DETACHED FROM THE HOUSING. RESIDUES OF ADHESIVE WERE NOTED IN THE STOPCOCK-HOUSING ASSEMBLY AREA. NO CONCLUSION COULD BE REACHED BASED ON THE ANALYSIS RESULTS AS TO WHAT MAY HAVE CAUSED THE FOUND CONDITION. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROBOTIC ASSISTED HYSTERECTOMY PROCEDURE, THE DEVICE'S STOPCOCK BROKE OFF WHEN CHANGING THE GAS LINE TO ANOTHER PORT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DILATING TIP TROCAR WITH STABILITY SLEEVE - 12 MM DIAMETER GCJ ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA R4TN3A

    Patients

    Seq Age Sex Outcome Treatment
    1