BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE HEMORRHOIDAL CIRCULAR STAPLER

    MDR report key: 478388 · Received August 13, 2003

    Report

    Report Number
    1527736-2003-01521
    Event Type
    Malfunction
    Date Received
    August 13, 2003
    Date of Event
    July 18, 2003
    Report Date
    July 18, 2003
    Manufacturer
    ETHICON ENDO-SURGERY, INC.(CINCINNATI)
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PPH PROCEDURE, THE PPH DID NOT FORM STAPLES CORRECTLY WHEN FIRED. ANOTHER PPH STAPLER GUN WAS FIRED AND WORKED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE HEMORRHOIDAL CIRCULAR STAPLER PROXIMATE HSC (PPH) SET KOG ETHICON ENDO-SURGERY, INC.(CINCINNATI) NA T4VK4R

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other