BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMARK TD MARKER SYSTEM

    MDR report key: 956886 · Received April 12, 2007

    Report

    Report Number
    3003862400-2007-00006
    Event Type
    Other
    Date Received
    April 12, 2007
    Date of Event
    March 14, 2007
    Report Date
    March 15, 2007
    Manufacturer
    SUROS SURGICAL SYSTEMS, INC
    Product Code
    FZZ
    PMA / PMN Number
    K023450
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TRAPDOOR COMPONENT ON THE TRIMARK TD'S ARE MEDICAL GRADE 304SS GRADE STAINLESS STEEL, AND ARE BIOCOMPATIBLE. EVENT WAS DUE TO A TRIPLE FAULT FAILURE MODE. EVALUATION RESULTS ARE INCLUDED IN SECTION B.

    Description of Event or Problem · 1

    DOCTOR USED THE ATEC TRIMARK TRAPDOOR (TD) 36-12 MARKER TO MARK THE SITE OF A BIOPSY. THIS PRODUCT IS USED IN CONJUCTION WITH THE ATEC 12 GAUGE HANDPIECES. DOCTOR FOUND INSERTION OF THE TRIMARK TD INTO THE HANDPIECE DIFFICULT, BUT MARKER WAS ABLE TO BE APPROPRIATELY DEPLOYED AT THE SITE OF BIOPSY. WHEN REMOVING THE TRIMARK TD FROM THE ATEC HANDPIECE, THE DOCTOR HAD TO USE EXCESSIVE FORCE TO SEPARATE THE TWO PIECES. UPON SEPARATION, THE DOCTOR NOTED THAT PART OF THE TRIMARK TD TRAPDOOR DEVICE HAD BECOME DETACHED, AND WAS LETF INSIDE THE PT. IT HAS BEEN IDENTIFIED THROUGH INTERNAL REVIEW THAT THE TRAPDOOR WAS PEELED UP DURING INSERTION INTO THE ATEC 12 GAUGE HANDPIECE, ULTIMATELY BENDING THE TRAPDOOR PORTION OF THIS PRODUCT BACKWARDS. IN ADDITION TO THIS FAILURE, THE TRIMARK TD UNIT THEN HAD TO BE PUSHED PAST THE OPENING IN THE HANDPIECE CANNULA SO THE BENT TRAPDOOR COULD BE CAUGHT OUTSIDE OF THE APERTURE. FINALLY, THE FORCE USED TO SEPARATE THE TRIMARK TD FROM THE HANDPIECE ULTIMATELY RESULTED IN A PIECE OF THE DEVICE SHEARING OFF A BEING LEFT BEHIND AT THE BIOPSY SITE. AFTER DISCUSSION WITH THE DOCTOR, IT WAS IDENTIFIED THAT HE DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU). ADDITIONALLY, THE IFU RECOMMENDS TO REMOVE THE ATEC TRIMARK/HANDPIECE AS A UNIT IF INITIAL RETRACTION OF THE TRIMARK TD IS DIFFICULT INDEPENDENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMARK TD MARKER SYSTEM BIOPSY SITE MARKER FZZ SUROS SURGICAL SYSTEMS, INC TRIMARK TD 36-12 610038

    Patients

    Seq Age Sex Outcome Treatment
    1 *