BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX ARTICNG

    MDR report key: 2093489 · Received May 18, 2011

    Report

    Report Number
    3005075853-2011-02038
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 25, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT STATED THAT THE DEVICE WAS NOT SEATED AND THE PACKAGE WAS NOT SEALED. IT ALSO STATES THAT TYVEK WAS WRAPPED AROUND THE JAW. THE PACKAGE WAS VISUALLY INSPECTED. TYVEK WAS PEELED BACK ON TWO OPPOSITE CORNERS OF THE BLISTER. TYVEK WAS NOT AROUND THE INSTRUMENT JAW. THERE WAS EVIDENCE OF COMPLETE SEAL TRANSFER AROUND ENTIRE CIRCUMFERENCE OF BLISTER FLANGE. TYVEK WAS EXAMINED UNDER BLACK LIGHT TO CONFIRM THAT SEAL TRANSFER HAD TAKEN PLACE ON ENTIRE BLISTER FLANGE, INCLUDING THE PORTIONS THAT HAD BEEN PEELED BACK. THE BLISTER WAS BOWED EITHER DUE TO STORAGE POSITION OR WEIGHT ON TOP OF THE PACKAGE. THE BLISTER WAS NOT BOWED PRIOR TO SEALING PROCESS OR THERE WOULD BE DIFFERENCES IN THE SEAL ADHESIVE TRANSFER TO THE BLISTER. THERE WERE NO CUTS OR HOLES IN THE TYVEK. IT CANNOT BE DETERMINED WHEN THE CORNERS OF THE TYVEK HAD BEEN PEELED OPEN. ALL PACKAGES AT EES ARE 100% VISUALLY INSPECTED PRIOR TO SHIPMENT. 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 PRIOR TO A COLECTOMY, THE DEVICE WAS PULLED AND IT WAS NOTED THAT THE DEVICE WAS NOT STERILE. THE DEVICE WAS NOT SEATED INTO THE PACKAGING MOLD AND THE TYVEK WAS NOT SEALED. THE TYVEK WAS WRAPPED AROUND THE JAW OF THE INSTRUMENT. MAKING THE DEVICE UNSTERILE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS FLEX ARTICNG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4UD1U

    Patients

    Seq Age Sex Outcome Treatment
    1