BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASER

    MDR report key: 15293767 · Received August 24, 2022

    Report

    Report Number
    MW5111717
    Event Type
    Injury
    Date Received
    August 24, 2022
    Date of Event
    August 15, 2022
    Report Date
    August 23, 2022
    Manufacturer
    UNK
    Product Code
    MQJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE MICRO-MANIPULATOR THAT AGILITY LASER COMPANY BRINGS WITH THEM THAT IS PLACED ON THE MICROSCOPE FOR VAGINAL LASER PROCEDURES WAS NOT WORKING PROPERLY. THE DOCTOR WAS NOT ABLE TO SAFELY DIRECT THE LASER FOR THE PROCEDURE, AS HE WAS MAKING LEFT AND RIGHT MOVEMENTS WITH THE MANIPULATOR THE LASER LIGHT WAS MOVING UP AND DOWN. PROCEDURE ABORTED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2343421 LASER POWERED LASER SURGICAL INSTRUMENT MQJ UNK
    2343422 AGILITI MICRO-MANIPULATOR MICROMANIPULATORS AND MICROINJECTORS, ASSISTED REPRODUCTION MQJ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention