BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP

    MDR report key: 2600574 · Received June 1, 2012

    Report

    Report Number
    1219930-2012-00462
    Event Type
    Injury
    Date Received
    June 1, 2012
    Date of Event
    May 17, 2012
    Report Date
    May 23, 2012
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
    Product Code
    FZP
    PMA / PMN Number
    K100242
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP CHOLE. ACCORDING TO THE REPORTER: DURING THE SECOND FIRING, THE CLIP WAS MALFORMED. THE TIP OF THE CLIP WAS SLIGHTLY CLOSED AT LOADING. A NEW DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 250CC. THERE WAS NO UNANTICIPATED TISSUE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP DISPOSABLE CLIP APPLIER FZP COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES N2A0538X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other