BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    55MM NTLC SELECTABLE RELOAD

    MDR report key: 2240696 · Received September 9, 2011

    Report

    Report Number
    3005075853-2011-03706
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Report Date
    August 19, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K092577
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4): SWING TAB IN LOCKED POSITION. THE ANALYSIS RESULTS FOUND THAT FOUR SR55 RELOADS WERE RECEIVED IN GOOD VISUAL CONDITION. THE CARTRIDGE RELOADS HAD THE SWING TAB IN THE LOCKED POSITION, AND THE PROXIMAL ONE DRIVER UP AND THE REMAINING DRIVERS WERE DOWN WITH STAPLES PRESENT. 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 THE CARTRIDGES WERE LOADED INTO THE DEVICE FOR FUNCTIONAL TESTING. THE DEVICE ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER SHAPE. 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, PLEASE NOTE THAT 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. THE DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. 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 RELOADS DID NOT STAPLE AT ALL. NO FURTHER INFORMATION IS AVAILABLE. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 55MM NTLC SELECTABLE RELOAD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 DEVICE