BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCULAR PROBES

    MDR report key: 4928287 · Received July 21, 2015

    Report

    Report Number
    1416980-2015-29550
    Event Type
    Malfunction
    Date Received
    July 21, 2015
    Report Date
    September 28, 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 CAUSE OF THE CONDITION COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. MICROSCOPIC INSPECTION WAS PERFORMED AND REVEALED A WHITE PARTICLE, APPROXIMATELY 1.8 MM LONG, WITHIN THE INNER POUCH. THE PARTICLE WAS NEAR THE PROBE SHAFT. THIS PARTICLE WAS DETERMINED TO BE A REMNANT FROM THE CARDBOARD PROBE HOLDER THAT IS INCLUDED IN THE PRIMARY PACKAGING. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE WAS DUE TO A MANUFACTURING PROCESS FAILURE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PARTICULATE MATTER WAS FOUND IN THE INNER POUCH OF A VASCULAR PROBE. THIS WAS IDENTIFIED DURING RECEIVING INSPECTION BY THE REPORTING FACILITY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472918 VASCULAR PROBES DILATOR, VESSEL, SURGICAL DWP SYNOVIS SURGICAL INNOVATIONS SPCE31502B0059

    Patients

    Seq Age Sex Outcome Treatment
    1