BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE-12MM DIAMETER, 75MM LENGTH

    MDR report key: 1831417 · Received December 20, 2007

    Report

    Report Number
    1527736-2007-08705
    Event Type
    Malfunction
    Date Received
    December 20, 2007
    Date of Event
    December 4, 2007
    Report Date
    December 13, 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). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE AIR LEAKED FROM THE DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE-12MM DIAMETER, 75MM LENGTH GCJ ETHICON ENDO SURGERY, INC. (CINCINNATI) NA D4H81D

    Patients

    Seq Age Sex Outcome Treatment
    1