BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT - THICK

    MDR report key: 2003916 · Received March 1, 2011

    Report

    Report Number
    3005075853-2011-00781
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 3, 2011
    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
    FR
    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. 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 Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THORACOTOMY PROCEDURE, THE DEVICE WOULD CUT BUT STAPLED PARTIALLY. DURING THE PROCEDURE, THE LAST 10 STAPLES WERE NORMALLY DELIVERED BUT WERE NOT CLOSED ON THE TISSUE. THE SECTION WORKED NORMALLY. NO IMPORTANT BLEEDING. THE SURGEON REMOVED THE 10 MALFORMED STAPLES AND FINISHED THE PROCEDURE WITH A MANUAL SUTURE. 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 - THICK STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4UJ63

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE