BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCULAR PROBE

    MDR report key: 745675 · Received July 25, 2006

    Report

    Report Number
    2183620-2006-00015
    Event Type
    Malfunction
    Date Received
    July 25, 2006
    Date of Event
    June 16, 2006
    Report Date
    July 25, 2006
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FKA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE VASCULAR PROBE WAS RETURNED TO SYNOVIS SURGICAL INNOVATIONS FOR EVALUATION. THE FAILURE MODE OF THE DEVICE COULD NOT BE DUPLCATED DURING THE EVALUATION. THE DEVICE MALFUNCTION IS INCONCLUSIVE. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PATIENT HAD A LUBAL PROCEDURE REQUIRING THE CREATION OF AN ANASTOMOSIS. THE SURGEON USED A VASCULAR PROBE TO PROVIDE STRUCTURE TO THE ANASTOMOSIS. AFTER CREATION OF THE ANASTOMOSIS, THE PROBE WAS REMOVED AND BROKE INTO 4 PIECES WHEN COMING THROUGH THE END OF THE TUBE. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASCULAR PROBE VESSEL DILATOR FKA SYNOVIS SURGICAL INNOVATIONS 745105 5714359-244554

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other