BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE*PPH PROCEDURE SET

    MDR report key: 1321110 · Received February 24, 2009

    Report

    Report Number
    3005075853-2009-01169
    Event Type
    Malfunction
    Date Received
    February 24, 2009
    Date of Event
    January 30, 2009
    Report Date
    February 2, 2009
    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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 02/24/2009: INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HEMIORRHOIDECTOMY PROCEDURE, THERE WAS AN INCOMPLETE CIRCLE OF STAPLED TISSUE AFTER FIRING. HAD TO HAND SEW TISSUE TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS EXTENDED BY 40 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE*PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA E4LX7P

    Patients

    Seq Age Sex Outcome Treatment
    1