BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITAL CARE COVER PROBE INTRAOP LF GEL 96*6

    MDR report key: 9244972 · Received October 25, 2019

    Report

    Report Number
    MW5090697
    Event Type
    Malfunction
    Date Received
    October 25, 2019
    Date of Event
    October 17, 2019
    Report Date
    October 23, 2019
    Manufacturer
    VITAL CARE INDUSTRIES, INC.
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING OUR PROCEDURE, WE UTILIZED A NEOPROBE DEVICE, WHICH REQUIRES A PROBE COVER FOR THE HAND-HELD DEVICE. THE OPERATING ROOM PROVIDES 2 DIFFERENT PROBE COVERS AND UPON INSPECTION OF BOTH COVERS, THE SURGEON CHOSE TO UTILIZE THE CARE INDUSTRIES INTRAOPERATIVE PROBE COVER. AT THE END OF THE CASE, UPON REMOVAL OF THE PROBE COVER, THE PROBE WAS FOUND TO HAVE TRACE AMOUNTS OF BLOOD ON THE END OF THE DEVICE AND UPON FURTHER INSPECTION OF THE PROBE COVER, A SMALL PERFORATION WAS FOUND IN THE COVER. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032156 VITAL CARE COVER PROBE INTRAOP LF GEL 96*6 DRAPE, SURGICAL KKX VITAL CARE INDUSTRIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1