BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** LINEAR STAPLER

    MDR report key: 3940801 · Received July 17, 2014

    Report

    Report Number
    3005075853-2014-05028
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 6, 2014
    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
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: ADJUSTING KNOB. THE ANALYSIS RESULTS SHOWED THAT THE TL90 DEVICE WAS RECEIVED WITH THE HANDLE OPEN AND WITHOUT CARTRIDGE PRESENT ON THE DEVICE. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITIONS OF THE RETURNED DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE DEVICE WAS NOTED TO HAVE THE LOCKOUT TAB AND THE ADJUSTING KNOB DAMAGED. THE DAMAGE TO THE TAB AND KNOB IS CONSISTENT WITH AN EXCESSIVE FORCE APPLIED TO THE ROTATING KNOB WHEN TRYING TO DIAL DOWN A LOCKED DEVICE, CAUSING THE DAMAGE TO THE KNOB. IT SHOULD BE NOTED THAT THE INSTRUMENT HAS BEEN DESIGNED WITH A LOCKOUT FEATURE, WHICH DURING THE FIRST APPLICATION, PREVENTS TURNING THE ADJUSTING KNOB UNLESS THE RETAINING PIN IS PUSHED COMPLETELY FORWARD. PLEASE REFERENCE THE INSTRUCTIONS FOR USE FOR ADDITIONAL INFORMATION. A BATCH RECORD REVIEW WAS PERFORMED AND THE BATCH HAD NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SUBTOTAL GASTRECTOMY PROCEDURE, WHEN USING THE STAPLER AND TRIED TO SHUT THE KNOB WAS STUCK, TO EXERT FORCE THE STAPLER WAS BROKE. ANOTHER LIKE 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
    418660 PROXIMATE** LINEAR STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4CP4M

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR