BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE PLUS MD MULTI-DIRECTIONAL RELEASE SKIN STAPLER - 35 WIDE

    MDR report key: 1112635 · Received August 11, 2008

    Report

    Report Number
    3005075853-2008-01039
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    July 18, 2008
    Report Date
    July 21, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    D4; H4, 6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A BREAST LUMPECTOMY PROCEDURE. THE DEVICE WAS HOLDING ONE SIDE OF THE INCISION, THE STAPLES WERE FORMING ON ONE-SIDE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE PLUS MD MULTI-DIRECTIONAL RELEASE SKIN STAPLER - 35 WIDE GDT ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1