BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH XCEL BLUNT TIP TROCAR

    MDR report key: 1810006 · Received November 12, 2007

    Report

    Report Number
    1527736-2007-07553
    Event Type
    Malfunction
    Date Received
    November 12, 2007
    Date of Event
    October 17, 2007
    Report Date
    October 22, 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). INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE THAT DURING CHOLECYSTECTOMY AIR LEAKED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH XCEL BLUNT TIP TROCAR GCJ ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1