BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** RELOADABLE LINEAR STAPLER

    MDR report key: 3240218 · Received July 22, 2013

    Report

    Report Number
    3005075853-2013-03663
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 27, 2013
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION UNAVAILABLE.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 OPEN SIGMOIDECTOMY, ALL STAPLES WERE MALFORMED AT THE 1ST FIRING. REINFORCEMENT MATERIAL WAS NOT USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339383 PROXIMATE** RELOADABLE LINEAR STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4CC1H

    Patients

    Seq Age Sex Outcome Treatment
    1