BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIDEFIRE LASER PROBE

    MDR report key: 8256919 · Received January 16, 2019

    Report

    Report Number
    MW5083191
    Event Type
    Injury
    Date Received
    January 16, 2019
    Date of Event
    July 20, 2018
    Report Date
    February 25, 2019
    Manufacturer
    MONTERIS MEDICAL CORP.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM REPORTER ON 02/27/2019 FOR MW5083191: WE WORKED WITH THE MFR AND IT WAS DETERMINED THAT THERE WAS NO EVIDENCE TO SHOW A MALFUNCTION IN THE SIDEFIRE LASER PROBE THAT CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT. THIS MDR IS RELATED TO MW5083191 WHICH WAS ORIGINALLY SUBMITTED TO THE FDA ON 17JAN2019. THIS MDR IS THE SUPPLEMENTAL TO THAT REPORT THAT INCLUDES THE FOLLOWING UPDATES: MFR LIST WAS PREVIOUSLY INCORRECT. THE CORRECT MFR IS CAPTURED WITHIN THIS REPORT. THE EVENT REPORT TYPE WAS PREVIOUSLY MARKED AS PRODUCT PROBLEM. THE REPORT TYPE IS SERIOUS INJURY AS INDICATED IN THIS REPORT. THE PREVIOUS REPORT STATED NO ADVERSE EVENTS. THE REPORT SHOULD HAVE STATED YES, AS INDICATED IN THIS REPORT. THE EVENT DESCRIPTION WAS INACCURATELY CAPTURED IN THE PREVIOUS REPORT AND IS UPDATED IN THIS REPORT. THE PREVIOUS REPORT ALSO DID NOT CALL OUT CONCOMITANT MEDICAL PRODUCTS WHICH ARE CAPTURED IN THIS REPORT.

    Description of Event or Problem · 1

    FDA RECALL IN RELATION TO INADVERTENT PROBE HEATING. PT TREATED WITH STEREOTACTIC LASER FOR INTRACTABLE EPILEPSY, TO AVOID A CRANIOTOMY. PT DEVELOPED COMPLICATIONS POST-OP RESULTING IN BLEEDING AND NEURO-DEFICITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48400 SIDEFIRE LASER PROBE NEUROBLATE PROBE POWERED LASER SURGICAL INSTRUMENT GEX MONTERIS MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other