BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** RELOADABLE LINEAR STAPLER - 30 MM

    MDR report key: 2150289 · Received July 6, 2011

    Report

    Report Number
    3005075853-2011-02758
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 13, 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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED SPRING PIN AND DAMAGED HANDLE. THE ANALYSIS RESULTS SHOWED THAT THE DEVICE ARRIVED WITH THE HANDLES OPENED AND THE FIRING MECHANISM DAMAGED. A RELOAD WAS RECEIVED FULLY LOADED WITH STAPLES. NO FUNCTIONAL TEST WAS PERFORMED WITH THE RETURNED DEVICE. HOWEVER, THE RETURNED RELOAD WAS TESTED FOR FUNCTIONALITY WITH A TEST DEVICE. THE DEVICE FIRED AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLES WERE NOTED TO HAVE A PROPER B-FORMATION AND THE STAPLE LINE WAS COMPLETE. AFTER FURTHER INSPECTION OF THE DEVICE, IT WAS NOTED THAT THE SPRING PIN WAS BENT. IT IS POSSIBLE THAT THE DEVICE WAS CLAMPED OVER AN EXCESS OF TISSUE OR A HARD OBJECT, OR ATTEMPTED TO FIRE ON A LOCKED RELOAD ENCOUNTERING HIGHER FIRING FORCES THAN NORMAL RESULTING IN DAMAGE TO THE SPRING PIN COMPONENT AND THE HANDLES. AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE STAPLES DID NOT COME OUT AFTER CLOSING THE FIRING TRIGGER. THE CLOSING TRIGGER "HAD THE CRACK." 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 PROXIMATE** RELOADABLE LINEAR STAPLER - 30 MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA H43D5X

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE