BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCULAR PROBES

    MDR report key: 4933066 · Received July 22, 2015

    Report

    Report Number
    1416980-2015-29878
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Report Date
    September 9, 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). THE SAMPLE WAS RETURNED FOR EVALUATION. MICROSCOPIC INSPECTION REVEALED A BLACK FIBER, APPROXIMATELY 1.0 MM LONG, BETWEEN THE INNER AND OUTER POUCHES. 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.

    Additional Manufacturer Narrative · 1

    (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PARTICULATE MATTER WAS OBSERVED INSIDE THE INNER POUCH OF A 15CM VASCULAR PROBE. THIS OBSERVATION WAS MADE PRIOR TO PATIENT USE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475701 VASCULAR PROBES DILATOR, VESSEL, SURGICAL DWP SYNOVIS SURGICAL INNOVATIONS SP15C031034839

    Patients

    Seq Age Sex Outcome Treatment
    1