BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH XCEL TROCAR

    MDR report key: 4180339 · Received October 17, 2014

    Report

    Report Number
    3005075853-2014-07163
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE B8LT COMPLAINT SAMPLE WAS VISUALLY INSPECTED. THE PACKAGE WAS OPEN ON ONE SIDE. IT WAS NOTED THAT THE PACKAGE WAS SEALED PRIOR TO THE DECONTAMINATION PROCESS THAT WAS COMPLETED PRIOR TO RECEIVING THE PACKAGE FOR ANALYSIS. AFTER THE DECONTAMINATION PROCESS, IT WAS NOTED THAT THE SEAL WAS OPEN. THE SEAL ON THE OPPOSITE SIDE OF THE PACKAGE WAS LIFTED FROM THE INSIDE, INDICATING THAT THE LIFT CAME FROM INTERNAL PRESSURE, WHICH ALIGNS WITH THE NOTES FROM THE DECONTAMINATION PROCESS. THERE WAS SEAL ADHESIVE PRESENT INDICATING THAT THE PACKAGE WAS SEALED AT PACKAGING FACILITY. IT WAS NOT CONFIRMED THAT THE PACKAGE HAD AN OPEN SEAL PRIOR TO DECONTAMINATION. LOT HISTORY RECORDS WERE REVIEWED AND THE PRODUCT MET ALL IN-PROCESS AND FINISHED GOODS SPECIFICATIONS UPON RELEASE OF THE PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN UNKNOWN PROCEDURE, IT WAS NOTED THAT THE BLISTER PACKAGING WAS OPEN, COMPROMISING STERILITY OF THE DEVICE. THE CASE WAS COMPLETED WITH A NEW DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663291 ENDOPATH XCEL TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA L4EJ6E

    Patients

    Seq Age Sex Outcome Treatment
    1