BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** RELOADABLE LINEAR STAPLER

    MDR report key: 3092187 · Received May 3, 2013

    Report

    Report Number
    3005075853-2013-02121
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EXTERNAL CAUSE. COMPLAINT INDICATED THAT THE POUCH WAS BROKEN BEFORE OPENING THE PACKAGE. THE PACKAGE WAS RETURNED FOR ANALYSIS, NO INDIVIDUAL CARTON WAS RETURNED. THE PACKAGE WAS VISUALLY INSPECTED AND IT WAS FOUND THAT THE INSTRUMENT WAS NOT SNAPPED INTO BLISTER DETENTS AND WAS OUT OF POSITION. THE STAPLE CARTRIDGE HAD BEEN DISLODGED FROM THE DEVICE AND WAS LOOSE INSIDE THE PACKAGE. THE TYVEK HAD A SMALL DAMAGE THAT DID NOT PENETRATE AND WAS NOT A HOLE. THE RIGID BLISTER WAS FOUND TO BE BROKEN AND A CRACK EXTENDED ON THE BLISTER. THE DAMAGE WAS NEAR THE LOCATION OF THE INSTRUMENT ANVIL. THE DAMAGE OCCURRED AFTER THE PACKAGE WAS SEALED AS THE CARTRIDGE IS NOT PACKAGED LOOSE IN THE BLISTER AND THE PACKAGES ARE 100% INSPECTED FOR THE OBSERVED DEFECTS. SIGNIFICANT IMPACT IS REQUIRED TO DISLODGE THE CARTRIDGE FROM THE INSTRUMENT. IT IS SUSPECTED THAT PACKAGE WAS IMPACTED DURING STORAGE AND HANDLING EXTERNAL TO THE PACKAGING FACILITY CAUSING THE DAMAGE TO THE BLISTER AND DISPLACEMENT OF THE CARTRIDGE FROM THE DEVICE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE POUCH WAS BROKEN BEFORE OPENING THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194344 PROXIMATE** RELOADABLE LINEAR STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4A36N

    Patients

    Seq Age Sex Outcome Treatment
    1