BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHEILDED TOTALVIEW ENDOILLUMINATION PROBE

    MDR report key: 6482040 · Received April 11, 2017

    Report

    Report Number
    1222074-2017-00001
    Event Type
    Malfunction
    Date Received
    April 11, 2017
    Date of Event
    March 14, 2017
    Report Date
    March 16, 2017
    Manufacturer
    DUTCH OPHTHALMIC
    Product Code
    FFS
    PMA / PMN Number
    K980636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE UNDERWENT AN INVESTIGATION AND IS NOW COMPLETE ON THE LIGHT FIBER PRODUCT 3269.SBS06, LOT 1905129 REPORTED AND RETURNED TO US. THE DEVICE HISTORY LOT REVIEW: THE LOT MEET THE SPECIFICATION OUTLINED FOR RELEASE. WE HAVE NOT RECEIVED ANY SIMILAR COMPLAINTS ON THIS LOT. WE HAVE NOT RECEIVED ANY INFORMATION OF SAME OR SIMILAR LIKE EVENTS THAT PERTAIN TO THIS LOT OR ON ANY OTHER LOT OF THIS SAME OR SIMILAR MANUFACTURED PRODUCT. SAMPLE ANALYSIS: IT WAS DETECTED THAT THE OUTSIDE OF THE FIBER WAS MELTED. THIS FIBER COMPONENT WAS PRODUCED AT A DIFFERENT MANUFACTURER. IT IS UNKNOWN HOW THIS OCCURRED. IT IS POSSIBLE THAT THE GLADDING OF THE FIBER WAS DAMAGED DURING PRODUCTION, THEREFORE HEAT WAS ABLE TO BUILD UP. CONCLUSION: THE LOT REPORTED MEETS THE SPECIFICATION OUTLINED FOR RELEASE AND IS CONSIDERED AN ISOLATED INCIDENT. PLEASE NOTE THAT SHOULD ANY FURTHER INFORMATION BE RECEIVED, WE WILL SUBMIT A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    A REPORT HAS BEEN RECEIVED REPORTING THAT THE PROBE HAD STARTED SMOKING. A CALL WAS PLACED TO USER FACILITY FOR ADDITIONAL INFORMATION. IT WAS REPORTED THE INCIDENT OCCURRED DURING SURGERY WHILE IDLE BUT CONNECTED TO THE LIGHT SOURCE. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266121 SHEILDED TOTALVIEW ENDOILLUMINATION PROBE ILLUMINATION PROBE FFS DUTCH OPHTHALMIC 1905129

    Patients

    Seq Age Sex Outcome Treatment
    1