BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLD RELOAD

    MDR report key: 2083567 · Received May 10, 2011

    Report

    Report Number
    3005075853-2011-01911
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 14, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER REPORTED THAT PACKAGE WAS BROKEN. ONE PACKAGE WAS RECEIVED FOR ANALYSIS WITH NO CARTON. PACKAGE WAS BRITTLE AND YELLOWED. YELLOWING OF THE PACKAGE SOMETIMES OCCURS DURING STERILIZATION PROCESS AND DOES NOT INDICATE ANY FAILURE OF PACKAGE INTEGRITY OR STERILIZATION. PACKAGE WAS VISUALLY EXAMINED FOR DAMAGE AND A RIP OR BREAK IN THE TYVEK WAS FOUND THAT IS FROM THE OUTSIDE IN AND IS ALIGNED WITH THE EDGE OF THE BLISTER FORM AND DEVICE. THE DAMAGE TO THE TYVEK APPEARS TO START AS A SCRAPE THAT DOES NOT BREAK THROUGH THE TYVEK AND APPEARS TO SCORE THE TYVEK IN A LINE THAT GOES DOWN THE LENGTH OF THE PACKAGE. IT APPEARS THAT COMPRESSION OF THE PACKAGE MAY HAVE CONTRIBUTED TO THE SEPARATION OF THE TYVEK ALONG THE SCORED LINE. THE RIP DOES NOT PENETRATE THE BLISTER FORM. DEFECT APPEARS TO BE AN ISOLATED INCIDENT, AS NO NONCONFORMANCES OR OTHER COMPLAINTS WERE ISSUED FOR SAME PROBLEM. COMPLAINT DATA AND NONCONFORMANCE DATA WAS REVIEWED FOR TIME PERIOD (B)(4), 2009 TO (B)(4), 2011. PACKAGING PROCESS WAS REVIEWED AND IT WAS CONCLUDED THAT NOTHING ON THE (B)(4) PROCESS COULD BE ESTABLISHED TO HAVE CAUSED THIS ISSUE. CAUSE AND TIME OF THE DAMAGE TO THE PACKAGE COULD NOT BE DETERMINED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    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, IT WAS DISCOVERED THAT THE STERILIZED PACKAGE OF THE PRODUCT WAS BROKEN BEFORE USE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOLD RELOAD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4UE0T

    Patients

    Seq Age Sex Outcome Treatment
    1