BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPPER MAC 3 OPTIC LARYNSCOPE BLADE

    MDR report key: 16683941 · Received April 4, 2023

    Report

    Report Number
    MW5116349
    Event Type
    Malfunction
    Date Received
    April 4, 2023
    Date of Event
    March 30, 2023
    Report Date
    March 31, 2023
    Manufacturer
    PROPPER MFG. CO., INC.
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    STERILE PROCESSING BROUGHT US A MAC 3 FIBER OPTIC LARYNGOSCOPE BLADES AND SHOWED US THAT THE OUTER COATING IS PEELING OFF. THEY EVEN STATED THAT THE TECH THAT WAS PROCESSING IT CUT HER HAND ON THE SHARP EDGES. WE IMMEDIATELY CHECKED OUR INVENTORY AND PULLED EVERYONE THAT WE COULD FIND. UPON FURTHER INSPECTION, THEY WERE ALL SHOWING THE SAME WEAR. STERILE PROCESSING HAS NOT CHANGED ANY CHEMICALS OR PROCEDURES FOR PROCESSING THE BLADES. THE BLADES WERE ORDERED FROM THE SHARN MEDICAL CATALOG. THEY WERE ORDERED SOME TIME LAST YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416094 PROPPER MAC 3 OPTIC LARYNSCOPE BLADE LARYNGOSCOPE, RIGID CCW PROPPER MFG. CO., INC. 19914500

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown