BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE, 5MM DIAMETER - 100 MM LENG

    MDR report key: 1081076 · Received July 21, 2008

    Report

    Report Number
    3005075853-2008-00603
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    July 9, 2008
    Report Date
    July 11, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE THAT THE PACKAGE HAD BEEN BROKEN BEFORE USE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE, 5MM DIAMETER - 100 MM LENG GCJ ETHICON ENDO-SURGERY, LLC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1