BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMACLIP DISPOSABLE CARTRIDGE, 10MM CLIPS

    MDR report key: 1082086 · Received July 25, 2008

    Report

    Report Number
    1320894-2008-00101
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    May 1, 2008
    Report Date
    July 23, 2008
    Manufacturer
    DESIGN STANDARDS CORP
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE ACTUAL DEVICE, WE WILL RETURN THIS DEVICE TO THE MANUFACTURING SITE FOR AN EVAL. AS SOON AS THE MANUFACTURING ENGINEERS HAVE COMPLETED THEIR INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "DURING A LAP-CHOLE PROCEDURE THE PERMACLIP CLOSED ON THE CYSTIC ARTERY. THE SURGEON HAD TO USE CLAMPS WITH CLIPS AND CUT ARTERY TO REMOVE THE PERMACLIP. NO PT INJURY WAS REPORTED. THE PROCEDURE WAS NOT ALTERED OR EXTENDED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMACLIP DISPOSABLE CARTRIDGE, 10MM CLIPS LAPARSCOPIC CLIPS FZP DESIGN STANDARDS CORP UNK 0706041

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK