BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCULAR PROBES

    MDR report key: 7095613 · Received December 7, 2017

    Report

    Report Number
    1416980-2017-09628
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Date of Event
    October 3, 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

    ADDITIONAL INFORMATION WAS ADDED TO TWO (2) DEVICES WERE RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND LOOSE PARTICULATE MATTER (PM) WAS IDENTIFIED ON THE INSIDE WALL OF THE INNER POUCH OF ONE UNIT. NO PM WAS FOUND IN THE SECOND UNIT. THE PM IN THE FIRST UNIT WAS ANALYZED MICROSCOPICALLY AND THE PM WAS DETERMINED TO BE A FIBER. THE SIZE OF THE PM WAS DETERMINED TO BE 0.80 MM SQUARED. BASED ON THE SIZE OF THE PM IDENTIFIED IT HAS BEEN DETERMINED THERE WAS NO PATIENT RISK. 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 PARTICULATE MATTER WAS OBSERVED IN THE INNER POUCH OF TWO (2) VASCULAR PROBES DURING INCOMING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876287 VASCULAR PROBES DILATOR, VESSEL, SURGICAL DWP SYNOVIS SURGICAL INNOVATIONS NA SP17H091243781

    Patients

    Seq Age Sex Outcome Treatment
    1