BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE PPH PROCEDURE SET

    MDR report key: 2902138 · Received January 8, 2013

    Report

    Report Number
    3005075853-2013-00145
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Report Date
    December 18, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051301
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A PROLASPE AND HEMORRHOIDECTOMY. THE SURGEON STATED THAT THE DEVICE IS NOT CUTTING WELL WHEN FIRING. THE STAPLE LINE IS WELL FORMED, HOWEVER REMOVING THE DEVICE IS DIFFICULT. REMOVAL INCLUDE 3/4 COUNTER CLOCKWISE TURN. IF DEVICE IS STILL DIFFICULT TO EXTRACT HE USES ANOTHER 1/2 TURN. THE SURGEON STATED IF STILL DIFFICULT HE HAS TO REMOVE THE DILATOR. THE SURGEON STATES HE HAS TO GIVE THE DEVICE A GENTLE "YANK" TO SEPARATE FROM THE TISSUE, MAKING THE CASE MORE DIFFICULT. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8900 PROXIMATE PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1