BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCULAR PROBES

    MDR report key: 4996812 · Received August 12, 2015

    Report

    Report Number
    1416980-2015-32168
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Report Date
    October 2, 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 DEVICE WAS RETURNED FOR EVALUATION. MICROSCOPIC INSPECTION WAS PERFORMED AND THERE WAS ONE BLACK FIBER, APPROXIMATELY 1.5 MM LONG, FOUND BETWEEN THE INNER AND OUTER POUCHES. 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)(4). REPORTER: PHONE NUMBER - (B)(6). THE EVENT WAS REPORTED TO HAVE OCCURRED ON AN UNKNOWN DATE IN (B)(6) 2015. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS PARTICULATE MATTER IN THE INNER POUCH OF A VASCULAR PROBE. 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
    528314 VASCULAR PROBES DILATOR, VESSEL, SURGICAL DWP SYNOVIS SURGICAL INNOVATIONS SP15C301041194

    Patients

    Seq Age Sex Outcome Treatment
    1