BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STREAMLINE SURGICAL SYSTEM

    MDR report key: 16856447 · Received May 2, 2023

    Report

    Report Number
    1000125279-2023-00016
    Event Type
    Injury
    Date Received
    May 2, 2023
    Date of Event
    April 6, 2023
    Report Date
    May 2, 2023
    Manufacturer
    NEW WORLD MEDICAL, INC.
    Product Code
    MRH
    UDI-DI
    00892064002010
    PMA / PMN Number
    K211680
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT WAS REVIEWED AND NO ISSUES WERE OBSERVED. PRODUCT FROM THIS LOT WAS MANUFACTURED, TESTED, AND RELEASED PER VALIDATED PROCEDURES. COMMUNICATION WITH THE DEVICE USER INDICATED THAT THE DEVICE TIP MAY HAVE INADVERTENTLY TOUCHED THE AFFECTED TISSUE WHEN PERFORMING THE PROCEDURE. PER THE DEVICE IFU, DESCEMET'S MEMBRANE TEAR IS A POTENTIAL ADVERSE EVENT FROM USAGE OF THE DEVICE. THE IFU WARNS, "TO AVOID TOUCHING THE CORNEAL ENDOTHELIUM AND IRIS WITH STREAMLINE" AS WELL AS CAUTIONING FOR ADEQUATE PHYSICIAN TRAINING. NWM REPRESENTATIVES PROVIDE APPROVED TRAINING OPTIONS TO PHYSICIANS. THE CAUSE OF THIS EVENT COULD BE ATTRIBUTED TO UNINTENDED USER ERROR.

    Description of Event or Problem · 0

    NWM SURGICAL SALES CONSULTANT REPORTED "POTENTIAL DESCEMET TEAR AFTER PERFORM STREAMLINE CLICK PULSE APPLICATIONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1534226 STREAMLINE SURGICAL SYSTEM INFUSION PUMP MRH NEW WORLD MEDICAL, INC. 10-0066 F1822 00892064002010

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other