BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PPH

    MDR report key: 2250835 · Received September 7, 2011

    Report

    Report Number
    2250835
    Event Type
    Malfunction
    Date Received
    September 7, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 7, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS USING THE PROXIMATE PPH03 STAPLER FROM THE HEMORRHOIDAL PROCEDURE SET AND REPORTED THE STAPLER MISFIRED. AFTER REPEATED ATTEMPTS TO GET THE STAPLER TO FIRE, THE STAPLE GUN WAS OPENED AND REMOVED FROM THE FIELD. THE PROCEDURE WAS COMPLETED WITHOUT USE OF THE STAPLE GUN. SOME STAPLES HAD BEEN INSERTED INTO THE MUCOSA AND SOME SQUEEZING OF THE PLATE OF MUCOSA BY TYING THE PURSE STRING WAS STILL PRESENT, BUT NO EXCISION OF THIS PLATE OF MUCOSA THAT WOULD BRING THE HEMORRHOIDS UP WAS ACHIEVED. THE PATIENT TOLERATED THE REMAINDER OF THIS PROCEDURE WELL WITHOUT FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PPH STAPLER, HEMORRHOIDAL PROCEDURE SET GDW ETHICON ENDO-SURGERY, INC. PPH03 H43V03

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR NO OTHER THERAPIES