BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDIGO LASER OPTIC DIFFUSER TIP

    MDR report key: 194626 · Received November 2, 1998

    Report

    Report Number
    194626
    Event Type
    Injury
    Date Received
    November 2, 1998
    Date of Event
    October 23, 1998
    Report Date
    October 23, 1998
    Manufacturer
    INDIGO MEDICAL, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A PROCEDURE INDIGO LASER PROBE TIP INDICATED A HIGH READING. CO CONTACTED STATED SOME PROBE TIPS HAVE BEEN TREATED WITH A CHEMICAL WHICH RESULTS IN INCORRECT TEMP READINGS. PROBE NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDIGO LASER OPTIC DIFFUSER TIP FIBEROPTIC DIFFUSER TIP GEX INDIGO MEDICAL, INC. LF 001 L4AG67

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention