BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCULAR PROBES

    MDR report key: 4919453 · Received July 16, 2015

    Report

    Report Number
    1416980-2015-29124
    Event Type
    Malfunction
    Date Received
    July 16, 2015
    Report Date
    September 30, 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. MICROSCOPIC INSPECTION WAS PERFORMED AND IDENTIFIED A BLACK FIBER, APPROXIMATELY 1.98 MM IN LENGTH, WITHIN THE INNER POUCH. THE REPORTED CONDITION WAS VERIFIED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE RELATED TO THE MANUFACTURING PROCESS. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463155 VASCULAR PROBES DILATOR, VESSEL, SURGICAL DWP SYNOVIS SURGICAL INNOVATIONS SP15C051035598

    Patients

    Seq Age Sex Outcome Treatment
    1