BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTANA HE 600 GLASS COVERSLIPS

    MDR report key: 11932799 · Received June 3, 2021

    Report

    Report Number
    2243471-2021-01617
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Date of Event
    March 22, 2021
    Report Date
    October 6, 2021
    Manufacturer
    VENTANA MEDICAL SYSTEMS INC
    Product Code
    KES
    PMA / PMN Number
    510K EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW-UP REPORT TO PROVIDE THE CASE CONCLUSION FOR . AN INVESTIGATION WAS PERFORMED TO EVALUATE THE CUSTOMER ISSUE. INVESTIGATION VERIFIED THAT SUPPLIER MANUFACTURING PROCESS WAS IN COMPLIANCE AND IN CONTROL. ADDITIONALLY, THERE ARE DIFFERING REASONS OF COVERSLIP REMOVAL FROM SLIDES. THERE ARE ADEQUATE PROCESSES IN PLACE FOR COVERSLIP REMOVAL USING GOOD LABORATORY PRACTICES (GLP). ALTHOUGH MULTIPLE COVERSLIPS COULD INCREASE THE NEED OF COVERSLIP REMOVAL FROM THE SLIDE THEREFORE POTENTIALLY LEADING TO CHANCES OF INJURIES DUE TO SHARPS, THE DEVICE OPERATOR'S MANUAL HAS ADEQUATE PRECAUTIONARY INSTRUCTIONS REGARDING PERSONAL INJURY AND INFECTION DUE TO SHARPS, ROUGH EDGES, AND/OR MOVING PARTS - GOOD LABORATORY PRACTICE CAN REDUCE THE RISK OF INJURY. TROUBLESHOOTING STEPS & PRECAUTIONARY STATEMENTS ARE PROVIDED TO CUSTOMERS/OPERATORS FOR STICKING COVERSLIPS THAT HELP MITIGATE RISK OF PERSONAL INJURY AND INFECTION. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER FROM THE UNITED STATES EXPERIENCED A RING FINGER INJURY, WHILE REMOVING DOUBLE COVERSLIPS FROM THE SLIDES OF THE HE 600 PLATFORM. IT WAS REPORTED THAT THE COVERSLIPS WERE IMPROPERLY APPLIED TO THE SLIDES. THE CUSTOMER WAS WEARING GLOVES AT THE TIME OF THE INCIDENCE. PER ADDITIONAL INFORMATION, NOT ALL GLASS PIECES WERE CLEANED FROM THE INJURY INITIALLY, DUE TO THE SIZE AND NUMBER OF GLASS PIECES, AND THE WOUND EVENTUALLY BECAME INFECTED. ON (B)(6) 2021, THE CUSTOMER VISITED THE EMERGENCY ROOM (ER) AND A SMALL INCISION WAS MADE ON THE INJURED FINGER TO REMOVE THE REMAINING GLASS PIECES. ACCORDING TO THE ER, DESPITE THE INTERVENTION, SOME GLASS PIECES REMAINED IN THE WOUND AND THE CUSTOMER WAS ASKED TO SELF MONITOR THE WOUND. IT WAS REPORTED THAT POST THE VISIT TO ER, THE CUSTOMER COULD IMMEDIATELY RESUME WORK AND THE USE RING FINGER AS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832767 VENTANA HE 600 GLASS COVERSLIPS COVERSLIPS, MICROSCOPE SLIDE KES VENTANA MEDICAL SYSTEMS INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1