BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIX UNIVERSAL CLIP APPLIER

    MDR report key: 3040009 · Received April 2, 2013

    Report

    Report Number
    MW5029608
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHEN PUTTING THE 4TH STAPLE ON THE COMMON BILE DUCT DURING THE LAP CHOLE PROCEDURE, THE CLIP APPLIER GOT STUCK AND WOULD NOT RELEASE, NOR OPEN. THUS THE SURGEON HAD TO USE ANOTHER INSTRUMENT IN ORDER TO PRY THE JAWS APART TO REMOVE CLIP APPLIER FROM COMMON BILE DUCT. NO ADVERSE EFFECTS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134366 EPIX UNIVERSAL CLIP APPLIER CLIP APPLIER FZP APPLIED MEDICAL CA500 1188187

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention