BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCULAR PROBE

    MDR report key: 4922373 · Received July 17, 2015

    Report

    Report Number
    1416980-2015-29333
    Event Type
    Malfunction
    Date Received
    July 17, 2015
    Date of Event
    May 1, 2015
    Report Date
    September 10, 2015
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    DWP
    PMA / PMN Number
    K130896
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. A MICROSCOPIC INSPECTION WAS PERFORMED AND REVEALED A GRAY MASS, APPROXIMATELY 3.0 MILLIMETERS LONG, WITHIN THE INNER POUCH. THE PHYSICAL PROPERTIES OF THE MASS ARE CHARACTERISTIC OF ROOM TEMPERATURE VULCANIZATION SILICONE RUBBER ADHESIVE. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VASCULAR PROBE CONTAINED PARTICULATE MATTER INSIDE ITS INNER POUCH. THIS WAS NOTED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465087 VASCULAR PROBE DILATOR, VESSEL, SURGICAL DWP SYNOVIS SURGICAL INNOVATIONS SP15D091043706

    Patients

    Seq Age Sex Outcome Treatment
    1