BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOSIX LP W/ECHO

    MDR report key: 2629730 · Received June 20, 2012

    Report

    Report Number
    1213643-2012-00477
    Event Type
    Malfunction
    Date Received
    June 20, 2012
    Date of Event
    May 24, 2012
    Report Date
    May 24, 2012
    Manufacturer
    DAVOL INC.
    Product Code
    FTL
    PMA / PMN Number
    K102766
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED, THEREFORE, AN EVAL COULD NOT BE PERFORMED. THE LOOP MAY HAVE BEEN INADVERTENTLY DAMAGED DURING DEPLOYMENT OR THROUGH INTERACTION WITH ANOTHER DEVICE, SUCH AS A GRASPER OR SUTURE PASSER. A REVIEW OF MFG RECORDS WAS PERFORMED AND NO DISCREPANCIES WERE FOUND. WITH THE AVAILABLE INFO, A DEFINITIVE CONCLUSION CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY A SALES REP: ON (B)(6) 2012 - THE SURGEON WAS PERFORMING A REPAIR PROCEDURE WITH A COMPOSIX L/P WITH ECHO, WHICH CONSISTS OF A MESH AND A REMOVABLE INFLATION POSITIONING SYSTEM. DURING THE PROCEDURE, WHEN GRABBING THE LOOP ON THE END OF THE TUBING WITH A GRANEE-NEEDLE GRASPER, THE LOOP CUT IN HALF. THE SURGEON THEN GRABBED THE TUBING RIGHT UNDER THE LOOP FIGURING IT WOULD BE MORE ROBUST, BUT IT ACTUALLY CUT THE LOOP OFF COMPLETELY. THE DOCTOR WAS ABLE TO RETRIEVE THE LOOP FROM INSIDE THE ABDOMEN RESULTING IN ONLY A SHORT DELAY IN THE PROCEDURE AND NO PT HARM WAS REPORTED. AS AN EVENT OF THIS NATURE COULD RESULT IN THE NEED FOR INTERVENTION TO LOCATE AND REMOVE THE DEVICE, AN MDR IS BEING FILED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPOSIX LP W/ECHO FTL DAVOL INC. HUVF1734

    Patients

    Seq Age Sex Outcome Treatment
    1 NA