BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER, MAKO

    MDR report key: 14549063 · Received May 31, 2022

    Report

    Report Number
    8043817-2022-00018
    Event Type
    Malfunction
    Date Received
    May 31, 2022
    Date of Event
    March 22, 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
    JA
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DRAPE WAS TORN DURING SURGERY. THERE WAS NO IMPACT TO THE PATIENT AND NO PATIENT INJURY OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1610492 STRYKER, MAKO ROBOTIC DRAPE PUI ECOLAB/MICROTEK MEDICAL INC. 111320 D211861 50748426117586

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown