BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISCOT

    MDR report key: 1081176 · Received July 11, 2008

    Report

    Report Number
    1081176
    Event Type
    Malfunction
    Date Received
    July 11, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 11, 2008
    Manufacturer
    VISCOT MEDICAL, LLC
    Product Code
    FZZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    A VISCOT BRAND SURGICAL MARKER WAS USED TO MARK A PATIENT'S LEFT LEG FOR A PHLEBECTOMY IN THE PRE-OP AREA. SOMETIME AFTER THE MARKING PROCEDURE, THE PATIENT CROSSED HIS LEGS, AND THE MARKER INK WAS TRANSFERRED TO THE RIGHT LEG, MAKING AN EXACT MIRROR COPY OF THE CORRECT MARK, WHICH WAS ON THE LEFT LEG. AFTER THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM, THE RIGHT LEG (WITH THE INCORRECT TRANSFERRED MARK) WAS DRAPED AND PREPPED. THE CORRECT SURGICAL MARK ON THE LEFT LEG WAS NOT DETECTED BY THE STAFF, DURING THE TIME-OUT PROCEDURE. HOWEVER, DURING EFFORTS TO SECURE THE PATIENT'S LEGS FROM THRASHING, PRIOR TO THE PROCEDURE, THE SURGICAL MARK ON THE LEFT LEG WAS OBSERVED AND PROCEDURE PREPARATION WAS STOPPED. THE CORRECT SURGICAL SITE WAS THEN VERIFIED, PREPPED AND THE PROCEDURE WAS PREFORMED AS PLANNED. TO PREVENT THIS ISSUE FROM OCCURRING IN THE FUTURE, THE OPERATING SURGEON WILL CLEARLY WRITE THE WORD 'YES' ON THE OPERATIVE LEG, WHICH IF TRANSFERRED TO THE OTHER LEG, WILL RESULT IN A BACKWARDS IMAGE. A SMILEY FACE OR OTHER IDENTIFIABLE SYMBOL WAS NOT SELECTED SINCE THE MIRROR IMAGE WOULD BE AN EXACT DUPLICATE OF THE ORIGINAL, AND NOT ALERT STAFF OF AN INCORRECT TRANSFERRED MARK. IN ADDITION, PATIENTS WILL NOW NOT BE ALLOWED TO LEAVE THE PREOPERATIVE AREA WITHOUT A 'YES' MARK, AND STAFF MEMBERS ARE ALSO REVISITING CURRENT OPERATING ROOM PROCEDURES, AND ARE WORKING WITH SURGEONS TO GET THEM MORE ACTIVELY INVOLVED IN THE TIME-OUT PROCEDURE.

    Description of Event or Problem · 1

    A VISCOT BRAND SURGICAL MARKER WAS USED TO MARK A PATIENT'S LEFT LEG FOR A PHLEBECTOMY IN THE PRE-OP AREA. SOMETIME AFTER THE MARKING PROCEDURE, THE PATIENT CROSSED HIS LEGS, AND THE MARKER INK WAS TRANSFERRED TO THE RIGHT LEG, MAKING AN EXACT MIRROR COPY OF THE CORRECT MARK, WHICH WAS ON THE LEFT LEG. AFTER THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM, THE RIGHT LEG (WITH THE INCORRECT TRANSFERRED MARK) WAS DRAPED AND PREPPED. THE CORRECT SURGICAL MARK ON THE LEFT LEG WAS NOT DETECTED BY THE STAFF, DURING THE TIME-OUT PROCEDURE. HOWEVER, DURING EFFORTS TO SECURE THE PATIENT'S LEGS FROM THRASHING, PRIOR TO THE PROCEDURE, THE SURGICAL MARK ON THE LEFT LEG WAS OBSERVED AND PROCEDURE PREPARATION WAS STOPPED. THE CORRECT SURGICAL SITE WAS THEN VERIFIED, PREPPED AND THE PROCEDURE WAS PREFORMED AS PLANNED. TO PREVENT THIS ISSUE FROM OCCURRING IN THE FUTURE, THE OPERATING SURGEON WILL CLEARLY WRITE THE WORD 'YES' ON THE OPERATIVE LEG, WHICH IF TRANSFERRED TO THE OTHER LEG, WILL RESULT IN A BACKWARDS IMAGE. A SMILEY FACE OR OTHER IDENTIFIABLE SYMBOL WAS NOT SELECTED SINCE THE MIRROR IMAGE WOULD BE AN EXACT DUPLICATE OF THE ORIGINAL, AND NOT ALERT STAFF OF AN INCORRECT TRANSFERRED MARK. IN ADDITION, PATIENTS WILL NOW NOT BE ALLOWED TO LEAVE THE PREOPERATIVE AREA WITHOUT A 'YES' MARK, AND STAFF MEMBERS ARE ALSO REVISITING CURRENT OPERATING ROOM PROCEDURES, AND ARE WORKING WITH SURGEONS TO GET THEM MORE ACTIVELY INVOLVED IN THE TIME-OUT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISCOT SURGICAL MARKER FZZ VISCOT MEDICAL, LLC 1451 *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR