BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUALASE

    MDR report key: 11796925 · Received May 10, 2021

    Report

    Report Number
    1723170-2021-01226
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    April 21, 2021
    Report Date
    June 1, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GAH
    UDI-DI
    00763000255954
    PMA / PMN Number
    K081656
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H2: ADDITIONAL INFORMATION ADDED TO THE EVENT DESCRIPTION. PATIENT INFORMATION RECEIVED. A4: PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED STATING THAT THE TYPE OF PROCEDURE BEING COMPLETED WAS A NEURO PROCEDURE.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 9735559, SERIAL/LOT #: (B)(4), UBD: 28-OCT-2022, UDI#: (B)(4). NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM. IT WAS REPORTED THAT AFTER A CASE THE NEURORADIOLOGIST INFORMED THE HEALTH CARE PROFESSIONAL THAT THE MRI TABLE GOT DAMAGED DUE TO LIQUID DISCHARGE. DURING THE CASE THERE WAS NO SIGN OF LIQUID LOSS OF THE COOLING CATHETER AND THERE WAS ALWAYS LIQUID RETURN. NO ONE IN THE OPERATING ROOM SAW ANY KIND OF LIQUID BUT IT CAN'T BE ABSOLUTELY EXCLUDED THAT THE ISSUE OCCURRED DURING THE CASE. THE PATIENT WASN'T IMPACTED AT ALL AND THE WHOLE CASE WENT WELL. ANY PATIENT FACTOR CAN BE EXCLUDED. NO TROUBLESHOOTING WAS PERFORMED AS NO ONE SAW AN ISSUE. ONLY AFTER THE CASE THE SITE GOT INFORMED ABOUT THE DAMAGE. THE PRODUCT HAD ALREADY BEEN DISCARDED WHEN THE ISSUE WAS REPORTED. NO PATIENT WAS PRESENT WHEN THE REPORTED ISSUE WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694182 VISUALASE POWERED LASER SURGICAL INSTRUMENT GAH MEDTRONIC NAVIGATION, INC 9735571 2020120539 00763000255954

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR "SEE H10...."