BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALIGHT ST W/ECHO

    MDR report key: 3231867 · Received July 10, 2013

    Report

    Report Number
    1213643-2013-00302
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 18, 2013
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K110820
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON WHAT WAS REPORTED, THE SURGEON DID NOT CUT THE INFLATION TUBE CLOSE TO THE SKIN WHERE IT EXITS THE BODY AS DESCRIBED IN THE INSTRUCTIONS FOR USE SUPPLIED WITH THE DEVICE, BUT INSTEAD CUT THE TUBE ABOVE THE ANCHOR. IT IS REPORTED THAT THE SURGEON HAS BEEN USING THE DEVICE FOR SOME TIME AND IS FAMILIAR WITH THE PROPER TECHNIQUE. BASED ON THE REPORTED INFORMATION, IT APPEARS THAT THE USER DID NOT FOLLOW THE PROPER INSTRUCTIONS AS OUTLINED IN THE PRODUCT'S INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL: IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A LAPAROSCOPIC HERNIA REPAIR ON (B)(6) 2013, USING DAVOL VENTRALIGHT ST WITH ECHO. AFTER THE IMPLANT WAS FIXATED INTO PLACE, THE SURGEON REPORTEDLY CUT THE INFLATION TUBE ABOVE THE YELLOW ANCHOR AFTER DEFLATING THE ECHO DEVICE. AS THE SURGEON ATTEMPTED TO REMOVE THE ECHO DEVICE BALLOON FROM THE BODY THE YELLOW ANCHOR BECAME STUCK BEHIND THE MESH AND COULD NOT BE PULLED FREE. THE SURGEON WAS UNABLE TO REMOVE THE ECHO BALLOON ASSEMBLY THROUGH THE CANNULA. THE SURGEON MADE AN ADDITIONAL INCISION TO ACCESS THE SITE AND REMOVE THE ECHO BALLOON ASSEMBLY. IT HAS BEEN REPORTED THAT THE ENTIRE DEVICE, INCLUDING THE ANCHOR, WAS REMOVED FROM THE PT. ASIDE FROM THE ADDITIONAL INCISION, THERE WAS NO ADVERSE PT OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316943 VENTRALIGHT ST W/ECHO FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUXD0454

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention