BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN DEBAKEY

    MDR report key: 10652490 · Received October 8, 2020

    Report

    Report Number
    3007208013-2020-00028
    Event Type
    Injury
    Date Received
    October 8, 2020
    Date of Event
    July 1, 2020
    Report Date
    October 16, 2020
    Manufacturer
    SYMMETRY SURGICAL INC
    Product Code
    DXC
    UDI-DI
    00887482011195
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ON 10/8/2020, ADDITIONAL INFORMATION WAS PROVIDED BY THE END USER THAT WAS NOT INITIALLY PROVIDED. THE END USER STATED THAT THE DEVICE SCISSORRED WHEN CLAMPING THE AORTA, THEREFORE DAMAGING IT DURING THE INITIAL PROCEDURE. OUR EVALUATION OF THE PRODUCT DID NOT CONFIRM THIS ISSUE. THE PRODUCT FUNCTIONED AS INTENDED WITH NORMAL USE. THE DEVICE WOULD ONLY SCISSOR WITH EXCESSIVE FORCE APPLIED WHILE TORQUING THE DEVICE AND PURPOSEFULLY MAKING IT SCISSOR. AS A RESULT, THERE IS NO EVIDENCE THAT THERE ARE ANY DEFECTS IN MATERIAL OR WORKMANSHIP OF THE DEVICE. THEREFORE, NO ADDITIONAL ACTIONS ARE NECESSARY.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOT CODE ON THE DEVICE INDICATES THAT THE DEVICE WAS MANUFACTURED IN 2005. UPON EVALUATION OF THE RETURNED INSTRUMENT, IT COULD NOT BE CONFIRMED THAT THERE WAS ANY ASPECT OUT OF CONFORMANCE. BASED ON THE EVALUTION OF THE DEVICE, IT CAN BE DETERMINED THAT THE INJURY THAT OCCURRED WAS NOT THE RESULT OF A MALFUNCTION OF THE DEVICE. THERE HAS BEEN A TOTAL OF 195 SOLD SINCE 2012 WITH NO ADDITIONAL COMPLAINTS RECORDED FOR THIS PRODUCT.

    Description of Event or Problem · 1

    AFTER THE INITIAL PROCEDURE, IT WAS NOTICED THERE WAS A SITE OF BLEEDING IN THE DESCENDING AORTA WHICH WAS COMPLICATED FURTHER BY AORTIC INJURY REQUIRING PLACEMENT OF AN INTERPOSITION GRAFT. THERE WAS CONTINUED BLEEDING FROM ALL THE SUTURE SITES. THEREFORE A COVERED STENT WAS PLACED IN THE AORTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1116294 CODMAN DEBAKEY MULTI-PURPOSE CLAMP DXC SYMMETRY SURGICAL INC 37-1173 0512 00887482011195

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention