BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER, MAKO

    MDR report key: 14549055 · Received May 31, 2022

    Report

    Report Number
    8043817-2022-00017
    Event Type
    Malfunction
    Date Received
    May 31, 2022
    Date of Event
    February 15, 2022
    Report Date
    May 31, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORT THAT THE DRAPE WAS PUNCTURED, WHICH WAS NOTICED WHEN THE BOX WAS OPENED. IT WAS REPORTED THAT THERE WAS NO IMPACT TO THE PATIENT AND NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1610484 STRYKER, MAKO ROBOTIC DRAPE PUI ECOLAB/MICROTEK MEDICAL INC. 111320 D212071 50748426117586

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown