BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STYKER, MAKO

    MDR report key: 14574711 · Received June 2, 2022

    Report

    Report Number
    8043817-2022-00020
    Event Type
    Malfunction
    Date Received
    June 2, 2022
    Date of Event
    May 16, 2022
    Report Date
    June 2, 2022
    Manufacturer
    ECOLAB/MICROTEK MEDICAL INC.
    Product Code
    PUI
    UDI-DI
    50748426117586
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A TEAR IN THE DRAPE ON BOTH THE OUTER AND INNER PACKAGING. THE TEAR WAS NOTICED PRIOR TO THE MEDICAL PROCEDURE. THERE WAS NO PATIENT IMPACT AND NO PATIENT INJURY OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159113 STYKER, MAKO ROBOTIC DRAPE PUI ECOLAB/MICROTEK MEDICAL INC. 111320 D191991 50748426117586

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown