BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** LINEAR STAPLER

    MDR report key: 4202675 · Received October 27, 2014

    Report

    Report Number
    3005075853-2014-07373
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 16, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4); DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION: JUST FOR CLARIFICATION, WAS THE STAPLE LINE IN COMPLETE (STAPLES MISSING FROM THE STAPLE LINE)? WHAT WAS THE APPEARANCE OF THE DEPLOYED STAPLES (B-SHAPED, IRREGULAR, LEGS STRAIGHT)? I WAS NOT IN THE CASE, BUT IT WAS REPORTED TO ME THAT THE STAPLES WERE NOT FORMED ON THE DISTAL PORTION OF THE STAPLE LINE. THE REST OF THE STAPLES DEPLOYED AND FORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COLON RESECTION PROCEDURE, THE SURGEON HAS ENCOUNTERED AN INCOMPLETE FIRING USING THE DEVICE. THE STAPLE LINE WOULD ONLY PARTIALLY FORM, LEAVING PART OF THE BOWEL OPEN. THERE WERE NO PATIENT CONSEQUENCES. CASE COMPLETED BY OVER SEWING THE STAPLE LINE. ONE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683524 PROXIMATE** LINEAR STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1