BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** LINEAR STAPLER

    MDR report key: 4213018 · Received October 30, 2014

    Report

    Report Number
    3005075853-2014-07475
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 8, 2014
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT THE TX30G DEVICE ARRIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD PRESENT. THE RELOAD WAS RECEIVED FULLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLES WERE NOTED TO HAVE A PROPER B-FORMATION AND THE STAPLE LINE WAS COMPLETE. A BATCH RECORD REVIEW WAS PERFORMED AND THE BATCH HAD NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, THE SURGEON THOUGHT THE DEVICE HAD FIRED ON THE COLON AND CUT THE COLON THINKING THE DEVICE HAD FIRED THE STAPLES. WHEN THE STAPLER WAS RELEASED THE STAPLES HAD NOT ENTERED THE COLON BUT WERE "FLOATING" ON TOP OF THE CARTRIDGE. THE COLON THEN LEAKED AS IT HAD NOT BEEN STAPLED. THE SCRUB NURSE THOUGHT THE SURGEON MAY HAVE FIRED THE DEVICE ACCIDENTALLY PRIOR TO CLASPING THE COLON AND FIRING, HOWEVER THIS CANNOT BE VERIFIED. THE PATIENT WAS OK AND A HAND ANASTOMOSIS PERFORMED TO CLOSE THE BOWEL. DELAY OF TEN MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695060 PROXIMATE** LINEAR STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1