BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDPOPATH XCEL DILATING TIP TROCAR WITH STABILITY SLEEVE- 12MM DIAMETER, 100MM S

    MDR report key: 1160680 · Received September 5, 2008

    Report

    Report Number
    3005075853-2008-01547
    Event Type
    Malfunction
    Date Received
    September 5, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 13, 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
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AFTER INSERTING A NEW DEVICE AN AIR LEAK WAS DISCOVERED. 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 ENDPOPATH XCEL DILATING TIP TROCAR WITH STABILITY SLEEVE- 12MM DIAMETER, 100MM S GCJ ETHICON ENDO-SURGERY, LLC NA E4KD5G

    Patients

    Seq Age Sex Outcome Treatment
    1