BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1973675 · Received January 31, 2011

    Report

    Report Number
    3005075853-2011-00343
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 10, 2011
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS CONFIRMED THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND FULLY FUNCTIONAL. WHEN TESTED FOR FUNCTIONALITY, THE DEVICE FIRED AND FORMED THE REMAINING 32 STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES AND THE STAPLES WERE NOTED TO HAVE THE PROPER BOX SHAPE. NO BATCH RECORD REVIEW COULD BE PERFORMED AS NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FACE LIFT PROCEDURE, AFTER THE FIRST FIRING, THE STAPLES WERE NOT STICKING IN THE SKIN. THEY WERE NOT COMPLETELY CLOSED. THEY WOULD CRAMP ON ONE SIDE AND NOT THE OTHER. A SECOND ONE WAS USED TO CONTINUE. THERE WAS NO IMPACT TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1