BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTRALIGHT ST W/ECHO

    MDR report key: 6276381 · Received January 25, 2017

    Report

    Report Number
    1213643-2017-00038
    Event Type
    Malfunction
    Date Received
    January 25, 2017
    Date of Event
    January 6, 2017
    Report Date
    January 25, 2017
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K122436
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RECOMMENDED MINIMUM SIZE TROCAR FOR PRODUCT CODE 5955680, AS STATED IN THE INSTRUCTIONS FOR USE, IS 12MM. AS REPORTED THE LARGEST SIZE THAT WAS USED ON THE PATIENT WAS 11MM. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. THE SAMPLE WAS NOT RETURNED FOR AN EVALUATION, THEREFORE, AT THIS TIME NO DEFINITIVE CONCLUSIONS CAN BE MADE. HOWEVER IT IS POSSIBLE THAT THE ISSUE EXPERIENCED BY THE USER WAS DUE TO HAVING USED A SMALLER SIZE TROCAR THAN IS RECOMMENDED IN THE INSTRUCTIONS FOR USE. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VENTRALIGHT ST W/ ECHO PS WAS BEING USED FOR A LAPAROSCOPIC VENTRAL HERNIA REPAIR. THE DEVICE WAS INTRODUCED INTO THE PATIENT AND AT THAT TIME THE SURGEON NOTED THE ECHO PS HAD COMPLETELY DETACHED FROM THE MESH. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND A NEW MESH WAS OPENED AND USED TO COMPLETE THE CASE. THE CONTACT REPORTS THAT AT THE TIME OF INSERTION THERE WERE FOUR TROCARS IN THE PATIENT THREE WERE 5MM AND ONE WAS AN 11MM. THE CONTACT REPORTS THAT SHE DOES NOT KNOW WHICH TROCAR SIZE THE MESH WAS INSERTED DOWN. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59925 VENTRALIGHT ST W/ECHO SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUAU1312

    Patients

    Seq Age Sex Outcome Treatment
    1