BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS CIRCULAR STAPLES

    MDR report key: 725903 · Received June 7, 2006

    Report

    Report Number
    1527736-2006-02591
    Event Type
    Malfunction
    Date Received
    June 7, 2006
    Date of Event
    May 17, 2006
    Report Date
    May 19, 2006
    Manufacturer
    ETHICON ENDO SURGERY, INC.
    Product Code
    GAG
    PMA / PMN Number
    k983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS NOT PROVIDED. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. (510(K)#K983536)

    Description of Event or Problem · 1

    DURING A LAR PROCEDURE, 2 STAPLES WERE UNFORMED. THE CLIP DROPPED OFF FROM ANOTHER DEVICE. IT WAS COMPLETED BY ADDITIONAL SUTURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE ILS CIRCULAR STAPLES GDW GAG ETHICON ENDO SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN