BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX

    MDR report key: 1993423 · Received February 10, 2011

    Report

    Report Number
    2027111-2011-00015
    Event Type
    Other
    Date Received
    February 10, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 10, 2011
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVAL AND NO LOT # HAS BEEN PROVIDED TO THE MFR FOR REVIEW. AN ENGINEERING ASSESSMENT OF THE INCIDENT IS CURRENTLY BEING CONDUCTED AND A FOLLOW-UP REPORT WILL BE SENT WITHIN 30 DAYS OR UPON COMPLETION OF THE EVAL.

    Description of Event or Problem · 1

    LAP CHOLE- "AFTER DOUBLE CLIPPING OF CYSTIC DUCT AND ARTERY, THERE WAS PERSISTENT BLEEDING DUE TO THE CLIP NOT CLOSING PROPERLY. THE HANDLE FULLY PRESSED." PT STATUS: DISCHARGED. "RE-CLIPPING WITH A THIRD CLIP USING THE SAME CLIP APPLIER AND THEN ELECTROCAUTERY, THE BLEED STOPPED AS RESULT OF THIS INTERVENTION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX NONE FZP APPLIED MEDICAL CA090 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention