BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** PLUS MD MULTI-DIRECTIONAL RELEASE SKIN STAPLER - 35 WIDE

    MDR report key: 2436576 · Received February 2, 2012

    Report

    Report Number
    3005075853-2012-00430
    Event Type
    Malfunction
    Date Received
    February 2, 2012
    Date of Event
    January 10, 2012
    Report Date
    January 11, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDT
    PMA / PMN Number
    K833357
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION:[SURGEON] HAS BEEN WORKING WITH THIS PRODUCT SINCE YEARS AND HAS OVER 20 YEARS OF SURGICAL EXPERIENCE AND KNOWS THE STEPS TO USE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE A WAS RETURNED IN GOOD VISUAL CONDITION AND FULLY FUNCTIONAL. WHEN TESTED FOR FUNCTIONALITY, THE DEVICE FIRED AND FORMED THE REMAINING 34 STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES AND THE STAPLES WERE NOTED TO HAVE THE PROPER BOX SHAPE. DEVICE B WAS RETURNED IN GOOD VISUAL CONDITION AND FULLY FUNCTIONAL. WHEN TESTED FOR FUNCTIONALITY, THE DEVICE FIRED AND FORMED THE REMAINING 31 STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES AND THE STAPLES WERE NOTED TO HAVE THE PROPER BOX SHAPE. DEVICE C WAS RETURNED IN GOOD VISUAL CONDITION AND FULLY FUNCTIONAL. WHEN TESTED FOR FUNCTIONALITY, THE DEVICE FIRED AND FORMED THE REMAINING 39 STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES AND THE STAPLES WERE NOTED TO HAVE THE PROPER BOX SHAPE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN COLORECTAL SURGERY PROCEDURE, APPARENTLY THE CLIPS DON'T CLOSE CORRECTLY AND OFTEN FALL OFF. THEY DON'T STICK TO THE SKIN. HIS SECOND COMPLAINT ABOUT THE PMW IS THAT OFTEN HE IS NOT ABLE TO REMOVE THE PMW STAPLER AFTERWARDS AS IT STICKS TO THE CLIPS AND THE SKIN. PROCEDURE WAS PROLONGED FIVE MINUTES. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE** PLUS MD MULTI-DIRECTIONAL RELEASE SKIN STAPLER - 35 WIDE REMOVABLE (SKIN) GDT ETHICON ENDO-SURGERY, LLC. NA H44W2P

    Patients

    Seq Age Sex Outcome Treatment
    1