BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILLUMINATED STEPPED LASERPROBE, 23G / 0.6 M WITH ALCON® CONNECTOR

    MDR report key: 6677806 · Received June 29, 2017

    Report

    Report Number
    1222074-2017-00002
    Event Type
    Malfunction
    Date Received
    June 29, 2017
    Report Date
    June 14, 2017
    Manufacturer
    DUTCH OPHTHALMIC USA
    Product Code
    HQF
    UDI-DI
    08717872016122
    PMA / PMN Number
    K031023
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY LOT REVIEW: THE LOT IS UNKNOWN. SAMPLE ANALYSIS: NO SAMPLE WAS RETURNED FOR AN EVALUATION. IT WAS REPORTED IT WAS SENT BACK TO US, HOWEVER HAS NOT BEEN RECEIVED. CONCLUSION: THE REPORTED COMPLAINT IS NOT CONFIRMED. AT THIS TIME, THIS COMPLAINT IS CLOSED. THE REPORT WAS FILED AS AN ADVERSE EVENT BY THE USER FACILITY AND THE FACILITY HAS NOT PROVIDED ANY INFORMATION THAT A PATIENT HAD AN OTHER SERIOUS IMPORTANT MEDICAL EVENT. THEREFORE AM SUBMITTING THIS AS A CORRECTION TO THE INITIAL REPORT FILED BY THE USER FACILITY.

    Description of Event or Problem · 1

    WE RECEIVED A MEDWATCH REPORT 1222074-2017-00001. A BOX WAS CHECKED OFF OF AN ADVERSE EVENT. THE USER FACILITY HAS BEEN CONTACTED FOR FOLLOW UP INFORMATION. IT HAS BEEN LEARNED THIS WAS NOT AN ADVERSE EVENT. THE REPORTER CLARIFIED THAT THE INCIDENT WAS DETECTED PRIOR TO SURGERY WHEN SETTING UP THE MACHINE THE LIGHT TURNED ON ALERTING THAT IS WAS NOT DETECTING THE PROBE. THE DEVICE WAS NOT USED. THEY USED ALTERNATIVE DEVICES FOR THE SURGERY WITHOUT FURTHER INCIDENT. THERE IS NO SAMPLE TO EVALUATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459479 ILLUMINATED STEPPED LASERPROBE, 23G / 0.6 M WITH ALCON® CONNECTOR ILLUMINATED LASER PROBE HQF DUTCH OPHTHALMIC USA 08717872016122

    Patients

    Seq Age Sex Outcome Treatment
    1