BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ENDO LINEAR CUTTER

    MDR report key: 6116992 · Received November 21, 2016

    Report

    Report Number
    3005075853-2016-06639
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    November 7, 2016
    Report Date
    November 8, 2016
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # N53N2T. THE ANALYSIS RESULTS FOUND THAT THE PSE45A DEVICE WAS RETURNED INSIDE ITS PACKAGE; THE PACKAGE WAS RETURNED PARTIALLY OPEN. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE BLISTER FROM THE PACKAGING WERE DAMAGED; THE BLISTER WAS FOUND TO BE BROKEN AT ONE OF THE SIDES OF THE PACKAGE. IN, ADDITION PIECES OF THE BROKEN BLISTER WERE STILL ATTACHED TO THE TYVEK. DUE TO THE DAMAGES FOUND ON THE PACKAGING AND THE DEVICE, A POSSIBLE CAUSE FOR THIS CONDITION IS DUE TO IMPROPER HANDLING DURING TRANSIT OR STORAGE; IT APPEARS THAT THE PACKAGE HIT A HARD SURFACE AND THIS CAUSED THE REPORTED EVENT. ALL EES PRODUCT IS 100% INSPECTED PRIOR TO RELEASE. THE INFORMATION YOU PROVIDED IS COMPILED MONITORED AND REVIEWED ON A ROUTINE BASIS FOR ANY ASSOCIATED TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. 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. THE LOT HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE THAT BEFORE A BARIATRIC PROCEDURE THERE WAS DAMAGED PACKAGING, COMPROMISING THE STERILITY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THE EVENT WAS NOTED BEFORE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768849 PWRD ENDO LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA N90J7U

    Patients

    Seq Age Sex Outcome Treatment
    1