BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS CIRCULAR STAPLERS

    MDR report key: 726466 · Received June 13, 2006

    Report

    Report Number
    1527736-2006-02702
    Event Type
    Malfunction
    Date Received
    June 13, 2006
    Date of Event
    May 22, 2006
    Report Date
    May 22, 2006
    Manufacturer
    ETHICON ENDO SURGERY, INC.(CINCINNATI)
    Product Code
    KOG
    PMA / PMN Number
    k940967
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H4: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. 510(K) NUMBER IS K940967.

    Description of Event or Problem · 1

    DURING A LAP COLECTOMY PROCEDURE, THE SURGEON WAS ATTEMPTING TO REMOVE BLUE SPIKE FROM CENTER ROD OF ANVIL. HE HAD A CLAMP ON THE CENTER ROD AND ANOTHER CLAMP ON THE DISTAL BLUE SPIKE. THE SPIKE BROKE OFF INSIDE THE CENTER ROD. HE HAD TO REMOVE THE ANVIL OPEN ANOTHER CUTTER TO COMPLETE THE PROCEDURE. NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE ILS CIRCULAR STAPLERS KOG KOG ETHICON ENDO SURGERY, INC.(CINCINNATI) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN