BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCULAR PROBES

    MDR report key: 7086732 · Received December 6, 2017

    Report

    Report Number
    1416980-2017-09596
    Event Type
    Malfunction
    Date Received
    December 6, 2017
    Date of Event
    August 2, 2017
    Report Date
    January 11, 2018
    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

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    SIX DEVICES WERE RECEIVED FOR EVALUATION. DURING VISUAL EXAMINATION, LOOSE PARTICULATE MATTER (PM) WAS PRESENT ON THE OUTSIDE WALL OF THE INNER POUCH FOR TWO UNITS, AND ON THE INSIDE WALL OF THE INNER POUCH FOR FOUR UNITS. MICROSCOPIC INSPECTION WAS PERFORMED AND THE LOOSE PM WAS DETERMINED TO BE FIBER FOR FIVE OF THE UNITS, AND A PARTICLE FOR ONE UNIT. THE FIBERS WERE MEASURED AND FOUR WERE DETERMINED TO BE LESS THAN 0.80MM² AND THIS UNIT MEETS SPECIFICATION. THE PARTICLE WAS DETERMINED TO BE LESS THAN 0.80MM² AND THEREFORE THIS UNIT MEETS SPECIFICATION. THE REPORTED CONDITION WAS NOT VERIFIED. ONE FIBER WAS DETERMINED TO BE LARGER THAN 0.80 MM² AND THEREFORE THIS UNIT DOES NOT MEET SPECIFICATION. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION WAS DUE TO AN UNKNOWN MANUFACTURING PROCESS. 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 THERE WAS PARTICULATE MATTER IN THE INNER POUCH OF SIX (6) VASCULAR PROBES. 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
    866376 VASCULAR PROBES DILATOR, VESSEL, SURGICAL DWP SYNOVIS SURGICAL INNOVATIONS NA SP17F271237184

    Patients

    Seq Age Sex Outcome Treatment
    1