BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE*PPH PROCEDURE SET

    MDR report key: 2032209 · Received March 29, 2011

    Report

    Report Number
    3005075853-2011-01241
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 5, 2011
    Report Date
    March 7, 2011
    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
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROLAPSE AND HEMORRHOIDECTOMY PROCEDURE, AFTER FOLLOWING THE PROPER PROCEDURE OF USING THE PPH, THE EXPERIENCED SURGEON FOUND THERE WAS NO STAPLE ON THE 6-12 (LEFT-SEMI CIRCLE) POSITION OF THE CIRCLE, ONLY THE 12-6 (RIGHT-SEMI CIRCLE) POSITION OF THE CIRCLE HAD STAPLE. THERE WAS SEVERE BLEEDING AFTER FIRING THE PPH AND THE SURGEON NEEDED TO MAKE COMPLEMENTARY SUTURE TO CLOSE THE ANASTOMOSIS AND CONTROL BLEEDING. NO UNIFORM STAPLES WERE FOUND IN THE ANAL CANAL OF THE PATIENT AND OTHER PLACES, E.G. SUCTION BOTTLE AND STERILE FIELD. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE*PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4UC2W

    Patients

    Seq Age Sex Outcome Treatment
    1