BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT

    MDR report key: 2913652 · Received January 14, 2013

    Report

    Report Number
    3005075853-2013-00210
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 19, 2012
    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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO HAVE DEVICE RETURNED. DEVICE LOCATION IS UNKNOWN. THE DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    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 NO CARTRIDGE WAS RECEIVED FOR ANALYSIS. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE BLADE CAME OFF THE RAIL (WENT FROM OUTSIDE TO INSIDE), THEN FELL APART. USED SAME LIKE PRODUCT TO COMPLETE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21595 PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4CH7C

    Patients

    Seq Age Sex Outcome Treatment
    1