BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE RH REG SKIN STAPLER

    MDR report key: 1070638 · Received July 1, 2008

    Report

    Report Number
    3005075853-2008-00236
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Report Date
    June 10, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDT
    PMA / PMN Number
    K833357
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 07/01/2008. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PORT PROCEDURE, THE STAPLES WERE NOT FORMING THE PROPER B SHAPE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE RH REG SKIN STAPLER GDT ETHICON ENDO-SURGERY, LLC. NA E4KJ40

    Patients

    Seq Age Sex Outcome Treatment
    1