BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH XCEL TROCAR

    MDR report key: 4204097 · Received October 27, 2014

    Report

    Report Number
    3005075853-2014-07402
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Report Date
    October 8, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K122512
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: HOW WAS THE PACKAGING COMPROMISED? WAS THERE ANY DAMAGE TO THE PACKAGING? IF YES, PLEASE DESCRIBE.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THERE WAS A TEAR/HOLE ON THE PEEL OFF WHITE TYVEK ABOUT 4MM IN SIZE RENDERING THE 2B12LT AS UNSTERILE. THE 2B12LT COMPLAINT SAMPLE WAS VISUALLY INSPECTED. IT WAS CONFIRMED THAT THERE WAS A HOLE PRESENT IN THE FMP LID. THE HOLE APPEARS TO HAVE BEEN CAUSED BY A SHARP OBJECT IMPACTING THE LID FROM THE OUTSIDE OF THE PACKAGE AND CAUSING A SNAG. THE PACKAGE APPEARS TO HAVE BEEN STORED OUTSIDE OF THE SALES UNIT CARTON AND EXPERIENCED COMPRESSION BASED ON THE EVIDENCE OF WRINKLES AND CREASES ON THE LID. THE EVIDENCE OF PRINTING ON THE LID IMPLIES THAT THE HOLE IN THE FMP LID WAS CAUSED AFTER THE LID WENT THROUGH FLEX PRINTING. EACH PACKAGE IS VISUALLY INSPECTED IMMEDIATELY AFTER SEALING AND PLACED INTO A SALES UNIT CARTON. THESE SALES UNIT CARTONS ARE THEN PLACED INSIDE OF A CORRUGATE SHIPPER BOX. THE CONDITION OF THE CARTON AND SHIPPER BOX COULD NOT BE VERIFIED BECAUSE NEITHER WAS RETURNED. THE DAMAGED FMP LID IS NOT CONSISTENT WITH ISSUES THAT ARE LIKELY TO OCCUR DURING THE PACKAGING PROCESS. IT IS SUSPECTED THAT DAMAGE TO THE FMP LID OCCURRED WHILE THE PACKAGE WAS OUTSIDE OF THE SALES UNIT CARTON AND COULD BE ATTRIBUTED TO STORAGE AND HANDLING EXTERNAL TO THE PACKAGING FACILITY. 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 A NURSE NOTICED THE PACKAGING WAS COMPROMISED WHEN PICKING A PRODUCT FOR A FUTURE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681577 ENDOPATH XCEL TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA L4F076

    Patients

    Seq Age Sex Outcome Treatment
    1