BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** LINEAR CUTTER RELOAD - STANDARD

    MDR report key: 2944269 · Received February 5, 2013

    Report

    Report Number
    3005075853-2013-00492
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 11, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INCOMPLETE/INTERRUPTED CYCLE. THE ANALYSIS RESULTS FOUND THAT THE RELOAD WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH THE PROXIMAL 34 DRIVERS UP WITHOUT STAPLES AND THE REMAINING DRIVERS DOWN WITH STAPLES PRESENT. THE RETURNED CARTRIDGE RELOAD HAD THE SWING TAB IN THE LOCKED POSITION, WHICH INDICATES THAT THE DEVICE'S FIRING CYCLE WAS INTERRUPTED. IT SHOULD BE NOTED THAT THE CARTRIDGE RELOAD IS DESIGNED TO LOCKOUT, AS A SAFETY FEATURE, IF ANY STAPLES HAVE BEEN FIRED FROM THE CARTRIDGE RELOAD. IN ADDITION FAILURE TO COMPLETE THE STROKE MAY RESULT IN INCOMPLETE STAPLE LINE. THE CARTRIDGE RELOAD WAS MANUALLY UNLOCKED AND IT WAS TESTED FOR FUNCTIONALITY WITH A TEST INSTRUMENT. THE DEVICE FIRED, CUT, AND FORMED ALL THE REMAINING STAPLES AS INTENDED. THE DEVICE FIRED WITH NO DIFFICULTIES AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ILEOCECAL RESECTION, SOME STAPLES WERE UNFORMED AND THE TARGET TISSUE WAS NOT CUT COMPLETELY WHEN THE DEVICE WAS USED ON THE ILEOCECAL AREA AT THE 4TH FIRING. THE FIRING WAS THE 4TH FIRING OF FUNCTIONAL END TO END ANASTOMOSIS, SO THE DEVICE WAS FIRED ACROSS SOME STAPLE LINES. ADDITIONAL SUTURE WAS PERFORMED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE DOCTOR THOUGHT THE FIRING KNOB WAS MOVED TILL THE DISTAL END DURING THE OPERATION. THE DOCTOR COMMENTED THAT THERE WAS A POSSIBILITY THAT THE FIRING KNOB HAD NOT BEEN MOVED FORWARD COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49333 PROXIMATE** LINEAR CUTTER RELOAD - STANDARD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1