BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM SURGICLIP S-9.0 TITANIUM

    MDR report key: 3609018 · Received January 27, 2014

    Report

    Report Number
    2647580-2014-00052
    Event Type
    Injury
    Date Received
    January 27, 2014
    Report Date
    January 7, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    FZP
    PMA / PMN Number
    K853650
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE SURGEON DESCRIBED OVERALL EXPERIENCES USING THE 134046 OPEN CLIP APPLIER DURING PROCEDURES THAT INCLUDED IN CLIP MISFIRING WHICH RESULTED IN CUTTING VESSELS, CLIP MALFORMATIONS/SCISSORING AND UNIT JAMMING BEFORE ALL THE CLIPS HAD BEEN FIRED. HE STATED THESE ISSUED HAD ALSO BEEN EXPERIENCED BY OTHER SURGEONS IN THE PVA PRACTICE. THE SURGEON STATED THAT ADD'L UNITS HAD TO BE USED TO REPLACE THE MALFUNCTIONED ONES AS WELL AS 15-20 MINUTES OF ADD'L PROCEDURE TIME FOR VESSEL REPAIRS AND TROUBLESHOOTING. SPECIFIC DATES, PROCEDURES AND PT INFO WERE NOT PROVIDED IN THE DISCUSSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58331 PREMIUM SURGICLIP S-9.0 TITANIUM DISPOSABLE CLIP APPLIER FZP COVIDIEN, FORMERLY USSC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other