BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO CLIP 5MM CLIP APPLIER

    MDR report key: 3030650 · Received March 25, 2013

    Report

    Report Number
    1219930-2013-00246
    Event Type
    Injury
    Date Received
    March 25, 2013
    Date of Event
    February 15, 2013
    Report Date
    March 18, 2013
    Manufacturer
    COVIDIEN, FORMERLY US
    Product Code
    FZP
    PMA / PMN Number
    K954435
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC CHOLECYSTECTOMY. ACCORDING TO THE REPORTER: THE CLIPS DID NOT CLOSE AS THEY SHOULD HAVE, CAUSING A LACERATION TO THE CYSTIC DUCT. THE DAMAGE WAS NOT IRREVERSIBLE. THERE WAS UNANTICIPATED TISSUE LOS AS A RESULT OF THIS PROBLEM. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122093 ENDO CLIP 5MM CLIP APPLIER DISPOSABLE CLIP APPLIER FZP COVIDIEN, FORMERLY US N1D0419

    Patients

    Seq Age Sex Outcome Treatment
    1 Other