BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIRECTIONAL LASER PROBE WITH DORC CONNECTOR (25 GAUGE / 0.5 MM)

    MDR report key: 10150000 · Received June 12, 2020

    Report

    Report Number
    1222074-2020-00045
    Event Type
    Malfunction
    Date Received
    June 12, 2020
    Manufacturer
    D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WITH REGARD TO THIS COMPLAINT, ONE 25 GAUGE DIRECTIONAL LASER PROBE WITH DORC CONNECTOR WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION OF THE RETURNED PRODUCT REVEALED NO ANOMALIES. FUNCTIONAL TESTING CONFIRMED THAT THE INTERNAL FIBER WAS BROKEN. THE OUTER JACKET OF THE FIBER, HOWEVER, WAS INTACT AND PREVENTED LASER LIGHT FROM EMERGING DIRECTLY. THOUGH ALL LASER PROBES ARE TESTED ON FUNCTIONALITY PRIOR BEING RELEASED FOR DISTRIBUTION, BREAKING OF THE INTERNAL FIBER IS A CONFIRMED DEFICIENCY WITH THIS PRODUCT TYPE. SINCE THE OPTICAL FIBER IS VERY FRAGILE, LASER PROBES SHOULD BE HANDLED WITH UTMOST CARE AT ALL TIMES TO PREVENT DAMAGE. - ATTACHMENT: [MIR2020-002521 FINAL REPORT SIGNED 1222074-2020-00045.PDF].

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT LASER LIGHT LEAKED FROM A CABLE OF THE LASER PROBE. THE NEW LASER PROBE WAS USED. THERE WAS NO INJURY TO THE PATIENT OR STAFF.

    Additional Manufacturer Narrative · 1

    COMPLAINT ARTICLE WAS REQUESTED BY D.O.R.C. FOR INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT LASER LIGHT LEAKED FROM A CABLE OF THE LASER PROBE. A NEW LASER PROBE WAS USED. THERE WAS NO INJURY TO THE PATIENT OR STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610841 DIRECTIONAL LASER PROBE WITH DORC CONNECTOR (25 GAUGE / 0.5 MM) OPHTHALMIC LASER SYSTEM BEAM GUIDE GEX D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. 2000407491

    Patients

    Seq Age Sex Outcome Treatment
    1