BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEROYAL

    MDR report key: 2595354 · Received May 29, 2012

    Report

    Report Number
    1060680-2012-00003
    Event Type
    Other
    Date Received
    May 29, 2012
    Date of Event
    April 3, 2012
    Report Date
    April 3, 2012
    Manufacturer
    DESIGN STANDARDS CORPORATION
    Product Code
    GAG
    PMA / PMN Number
    K934105
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    END USER: THE HOSPITAL REPORTED THAT THE STAPLES FROM A ROTATING HEAD SKIN STAPLER CAME OUT OF TWO PTS ON THE WAY HOME FROM AN OPEN LAPAROTOMY PROCEDURE. THE DOCTOR HAD TO HAVE THE PTS COME BACK IN AND RE-CLOSE THE INCISION SITE. THE OPERATING ROOM DIRECTOR, MATERIALS MANAGER, AND DOCTOR ALL DEMONSTRATED STAPLING PROCEDURE ON A BLOCK OF FOAM. THE ROTATING HEAD SKIN STAPLER HAD ISSUES WITH MISS FORMED STAPLES. DEROYAL: THE STAPLER IS A VENDOR SUPPLIED RAW MATERIAL. THE END USER DISPOSED OF THE TWO STAPLERS USED IN THE PROCEDURES. THE STAPLER USED IN THE HOSPITAL EVALUATION WITH A BLOCK OF FOAM WAS RETURNED TO THE COMPLAINT INVESTIGATOR. IT APPEARED TO HAVE NO DEFECT. THE SALES REPRESENTATIVE INDICATED THE HOSPITALS INVENTORY WAS OKAY.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT THE STAPLES FROM A ROTATING HEAD SKIN STAPLER CAME OUT OF TWO PTS ON THE WAY HOME FROM AN OPEN LAPAROTOMY PROCEDURE. THE DOCTOR HAD TO HAVE THE PTS COME BACK IN AND RE-CLOSE THE INCISION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEROYAL ROTATING HEAD SKIN STAPLER GAG DESIGN STANDARDS CORPORATION 25-1001 27055440

    Patients

    Seq Age Sex Outcome Treatment
    1