BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** LINEAR CUTTER RELOAD - STANDARD

    MDR report key: 2802943 · Received October 24, 2012

    Report

    Report Number
    3005075853-2012-04851
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 27, 2012
    Report Date
    September 27, 2012
    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). UPON REVIEW OF THE ADDITIONAL INFORMATION PROVIDED, IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR A REPORTABLE EVENT, AND IS BEING CONSIDERED NOT REPORTABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED CARTRIDGE. THE ANALYSIS RESULTS FOUND THAT THE RELOAD WAS RECEIVED WITH THE LEFT GRIPPING SURFACE BROKEN OFF. THE RELOAD HAD THE PROXIMAL 6 DRIVERS UP WITHOUT STAPLES AND THE REMAINING DRIVERS WERE DOWN. IT COULD NOT BE DETERMINED IF THE REPORTED INCIDENT WAS THE RESULT OF A PREMATURE LOCKOUT, OR THE RESULT OF AN INTERRUPTED FIRING STROKE. THE SWING TAB WAS RESET AND THEN THE RELOAD WAS TESTED FOR FUNCTIONALITY WITH A TEST INSTRUMENT AND IT PERFORMED AS INTENDED. WHILE NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT, IT SHOULD BE NOTED THAT 100% INSPECTION IS PERFORMED BY MEANS OF AUTOMATED VISION SYSTEM TO INSURE THE SWING TAB IS PRESENT AND UNLOCKED. IN ADDITION, WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE GRIPPING SURFACE BECAME DAMAGED, IT SHOULD BE NOTED THAT 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. ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN AUTOMATED VISION SYSTEM, AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE.

    Description of Event or Problem · 1

    THE DEVICE PARTIALLY FIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, MOST OF THE STAPLES DIDN'T COME OUT AFTER THE FIRING. THE STAFF CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. NO ADVERSE EVENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE** LINEAR CUTTER RELOAD - STANDARD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4AG36

    Patients

    Seq Age Sex Outcome Treatment
    1