BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN CRANIAL ACCESS KIT (EA)

    MDR report key: 3812760 · Received May 15, 2014

    Report

    Report Number
    1226348-2014-11638
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    March 9, 2012
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GWM
    PMA / PMN Number
    PK914479
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THE EVALUATION OF THE INSTRUMENT REVEALED THAT THE LATCH IS OUT OF ADJUSTMENT. IT APPEARS THAT THE LATCH WAS MANIPULATED RESULTED IN BENDING, THE BENT NATURE OF THE LATCH PREVENTS PROPER FUNCTION. THE EXACT MANNER IN WHICH THE LATCH BECAME BENT CAN NOT BE VERIFIED, HOWEVER; THE LATCH CAN BE EASILY MANIPULATED / BENT. IT IS LIKELY THAT HANDLING/MANIPULATION BY THE CUSTOMER RESULTED LATCH BECOMING BENT. THIS INSTRUMENT WAS EVALUATED BY THE ENGINEERING DEPARTMENT AND IT WAS VERIFIED THAT THERE WERE NO "BROKEN" COMPONENTS OR OTHER DEFECTS NOTED ON THIS INSTRUMENT. THIS COMPLAINT IS ASSOCIATED WITH MANIPULATION OF THE LATCH AND IS NOT ASSOCIATED WITH MANUFACTURING DEFECTS. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    MEDWATCH REPORT EXPLAINED THAT THE RETRACTOR BROKE WHILE DOING A CRANIAL PROCEDURE-HAD TO BE HELD MANUALLY TO FINISH PROCEDURE. PATIENT NOT HARMED. IN PHONE CONVERSATION WITH THE CUSTOMER ON (B)(6) IT WAS EXPLAINED THAT THERE WAS NO DELAY IN THE PROCEDURE AS A MED STUDENT SCRUBBED IN AND HELD THE SITE OPEN. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291297 CODMAN CRANIAL ACCESS KIT (EA) DEVICE, MONITORING, INTRACRANIAL PRESSURE GWM CODMAN & SHURTLEFF, INC. 092

    Patients

    Seq Age Sex Outcome Treatment
    1