BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** RELOADABLE LINEAR STAPLER

    MDR report key: 2243278 · Received September 12, 2011

    Report

    Report Number
    3005075853-2011-03725
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    August 18, 2011
    Report Date
    August 29, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD LOADED ON THE DEVICE. THE RELOAD WAS RETURNED VOID OF STAPLES. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT CYCLED, FIRED, AND ALL THE STAPLES FORMED AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, THE SURGEON'¿S DESCRIPTION OF EVENTS: THE DEVICE WAS PLACED AT SITE FOR DISTAL TRANSECTION, RETAINING PIN WAS PLACED, AND THE DEVICE CLOSED. THE STAPLE HEIGHT INDICATOR WAS IN THE GREEN ZONE, THE SAFETY REMAINED ON UNTIL THE DEVICE WAS FIRED, AND THE DEVICE FELT NORMAL TO FIRE. THE TRANSECTION WAS COMPLETED WITH A SCALPEL AND THE DEVICE WAS THEN OPENED. IT APPEARED AS THOUGH NO STAPLES HAD BEEN DEPLOYED INTO THE TISSUE, AND THE BOWEL EDGES FELL APART EXPOSING THE LUMEN. OPEN, UNFORMED STAPLES WERE NOTED TO BE SCATTERED AROUND THE PELVIS. A DOUBLE PURSE-STRING TECHNIQUE WAS EMPLOYED FOR THE CIRCULAR-STAPLED ANASTOMOSIS. PATIENT OUTCOME WAS NOT DEEMED TO BE ADVERSELY AFFECTED. SURGERY WAS PROLONGED FIVE MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE** RELOADABLE LINEAR STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA H43Y7J

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE