BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT

    MDR report key: 1930105 · Received December 16, 2010

    Report

    Report Number
    3005075853-2010-07189
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 30, 2010
    Report Date
    December 1, 2010
    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). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH NO RELOAD PRESENT. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED AND CUT WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE, THE CUT LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. EVENT COULD NOT BE CONFIRMED AS THE FIRING KNOB WORKED WITHOUT ANY DIFFICULTIES NOTED DURING THE FUNCTIONAL TEST. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4).INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION: THERE WERE NO DIFFICULTY ON THE FIRING. THE DEVICE WAS NOT FIRED ACROSS THE HARD OBJECT. THE TARGET TISSUE WAS CLAMPED EVENLY IN THE JAW AND WAS NOT SO THICK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRECTOMY PROCEDURE, THE FIRING KNOB WAS HARD AND DIFFICULT TO RETURN TO THE HOME POSITION AFTER THE FIRST FIRING. THE KNOB WAS RETURNED TO THE HOME POSITION FORCIBLY. SOME STAPLES WERE UNFORMED. REINFORCEMENT MATERIAL WAS NOT USED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4TL2H

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE