BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMIVA

    MDR report key: 19327248 · Received May 15, 2024

    Report

    Report Number
    3006404071-2024-00005
    Event Type
    Injury
    Date Received
    May 15, 2024
    Date of Event
    April 24, 2024
    Report Date
    May 15, 2024
    Manufacturer
    SPINESMITH HOLDINGS,LLC
    Product Code
    DWG
    PMA / PMN Number
    K130689
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER DETAILS WILL BE ADDED AS MORE INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 0

    CUSTOMER TO RECEIVE TRAINING FOR THIER RF+ AS SCHEDULED. UPDATE: SEE B5 OF THIS SUBMISSION.

    Description of Event or Problem · 0

    CUSTOMER REPORTED BURNS WHILE USING A LOANER DEVICE. CUSTOMER INITIALLY SENT IN THE DEVICE WITHOUT NOTIFICATION. SPINESMITH PERSONNEL INVESTIGATED AND WERE THE INFORMED THAT AN ADVERSE EVENT HAD OCCURED. CUSTOMER SUPPORT WAS NOTIFIED ON 04/24/2024 AND THE CALLER INDICATED THAT THE EVENT HAD OCCURED ON 04/16/24. CUSTOMER REPRESENTATIVE IS WORKING ON GETTING ADDITIONAL INFORMATION FOR THE FILE. ALTHOUGH THERE IS LIMITED DETAILS, OTHER THAN THERE WERE BURNS DURING USE OF THE VA ELECTRODE. IT HAS BEEN DETERMINE BY THE ADVERSE EVENT DOC QS-116.F1.2 COMPLETED 04.24.24, THAT A REPORT WILL BE MADE WITHIN 30 DAYS OF THE REPORT REGARDLESS WITH THE INFORMATION PROVIDED TO INITIATE THE REPORT INTO EMDR. ONCE MORE INFORMATION IS COLLECTED A FOLLOW UP CAN BE ENTERED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED BURNS WHILE USING A LOANER DEVIVE. CUSTOMER INITALLY SENT IN THE DEVICE WITHOUT NOTIFICATION. SPINESMITH PERSONNEL INVESTIGATED AND WERE THE INFORMED THAT AN ADVERSE EVENT HAD OCCURED. CUSTOMER SUPPORT WAS NOTIFIED ON 04/24/2024 AND THE CALLER INDICATED THAT THE EVENT HAD OCCURED ON (B)(6) 2024. CUSTOMER REPRESENTATIVE IS WORKING ON GETTING ADDITIONAL INFORMATION FOR THE FILE. ALTHOUGH THERE IS LIMITED DETAILS, OTHER THAN THERE WERE BURNS DURING USE OF THE VA ELECTRODE. IT HAS BEEN DETERMINE BY THE ADVERSE EVENT (B)(4) COMPLETED 04.24.24, THAT A REPORT WILL BE MADE WITHIN 30 DAYS OF THE REPORT REGARDLESS WITH THE INFORMATION PROVIDED TO INITIATE THE REPORT INTO EMDR. ONCE MORE INFORMATION IS COLLECTED A FOLLOW UP CAN BE ENTERED. UPDATE: CUSTOMER SENT IN THE LOANER DEVICE AND VA ELECTRODE THAT WAS BEING USED DURING THE PROCEDURE. RFDE-VA-1 LOT# L23K037 WAS SENT TO THE MENUFACTURER (PHASE(N)) FOR INVESTIGATION AND THE LOANER DEVICE SN#(B)(6) WAS SUBMITTED TO THE SERVICE DEPARTMENT FOR INVESTIGATION. PHASE(N) REPORTED THAT THEY INSPECTED THE VA ELECTRODE PER DOC# FQA021-F01 REV.C AND RESULTS TESTED WITHIN SPECIFICATIONS. DHRS FOR THE FINAL ASSEMBLY VA ELECTRODE AND SUBASSEMBLIES WERE REVIEWED AND SHOWED NO ANOMALIES. PHASE(N) NOTIFIED SPINESMITH AND REPORTED THAT CASE WILL BE CLOSED WITH A "NO PROBLEM FOUND" DISPOSITION. IN-HOUSE SPINESMITH SERVICE EVALUATED THE LOANER THERMIVA DEVICE SN#(B)(6) IN ACCORDANCE WITH CS-01.F3.1 INVESTIGATION FORM AND CS-101.F1.5 THERMIREVS TESTING FORM. RESULTS TESTED WITHIN SPECIFICATIONS. SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE CUSTOMER CLAIM. CUSTOMER REPRESENTATIVE WAS NOTIFED AND CUSTOMER IS CURRENTLY USING THEIR ORIGINALLY OWNED GENERATOR WITH NO ISSUE. CUSTOMER REPRESENTATIVE DID REPORT THAT A DISCUSSION WAS HAD WITH DR. (B)(6) AND THE PHYSICIAN EXPLAINED THAT THE INDIVIDUAL PERFORMING THE PROCEDURE HAD NOT BEEN TRAINED YET TO OPERATION THE THERMI DEVICE. THE INDIVDUAL WAS SET TO RECEIVE TRAINING ON THE FOLLOWING FRIDAY. THE REPRESENTATIVE INFORMED THE DR. THAT THIS EVENT AND INFORMATION WILL BE DOCUMENTED AND THEY WILL CONTINUE TO MONITOR USAGE AND THE CUSTOMER REPRESENTATIVE WILL REPORT ANYTHING CHANGES TO THE COMPLAINT HANDLING TEAM AT SPINESMITH. BASED ON THE INVESTIGATION FINDINGS AND THE RESPONSE FROM DR.(B)(6) REPORT, THE IN-HOUSE COMPLAINT WILL BE CLOSED. THE FINDINGS OF THE EVENT CONCLUDED THAT THE EVENT OCCURRED BECAUSE IF USER ERROR AND DOES NOT INDICATE FAULT ON THE DEVICE OR ACCESSORY USED. FINAL CF REPORT READS AS FOLLOWS: CUSTOMER - (B)(6) - REPORTED THAT THEIR LOANER THERMIVA DEVICE PRODUCED A BURN DURING A VA TREATMENT. SN# (B)(6). INITIALLY THE DEVICE ARRIVED ON SITE WITH NO PRIOR INFORMATION OR ASSOCIATED RMA. IMMEDIATE INVESTIGATION REVEALED THAT THE CUSTOMER SENT IN THEIR DEVICE WITHOUT NOTIFICATION. SERVICE COMPLETED TESTING IN ACCORDANCE WITH CS-101.F1.5 THERMI REVS TESTING FORM. ALL RESULTS TESTED WITHIN SPECIFICATIONS. INITIAL DISCUSSION INDICATED THAT THE CUSTOMER MAY HAVE HAD AN ADVERSE EVENT BUT NO INFORMATION WAS PROVIDED BY THE CUSTOMER. HOWEVER, AN EMDR WAS INITIATED ON 05/15/2024 WITH THE INTENTION SO PROVIDING A FOLLOW-UP AS SOON AS THEIR WAS MORE DETAILS. WAS SENT 03/2/25 WITH DETAILS RECEIVED FROM THE CUSTOMER AND REPRESENTATIVE. (B)(4) ADVERSE EVENT DETERMINATION FORM ATTACHED. EMDR SUBMITTED 3006404071-2024-00005 ON 05/15/2024. EVALUATION NOTES WERE AS FOLLOWS: SALES REP (B)(6), CUSTOMER REPRESENTATIVE, REPORTED ON 4/24/24 WITH THE PROVIDER ON THE LINE TO DISCUSS AN EVENT THAT RESULTED IN A BURN. THE PROVIDER WAS USING A LOANER THERMIVA GENERATOR (SER# (B)(6)) ON A PATIENT. SHE WAS DOING A THERMI VA TREATMENT AND HAD SET THE UNIT TO 35C TO START THE PROCEDURE. SHE TOUCHED THE PATIENT ON THE OUTSIDE NEAR THE PERINEUM AND IT SHE NOTICED IT PRODUCED A BURN. BY THE END OF THE PROCEDURE, SHE NOTICED FOUR BURNS IN THE AREA. THE PROVIDER ALSO STATED THAT THERE WAS A FAULT THAT OCCURRED WHEN SHE PULLED AWAY FROM THE PATIENT, BUT THEY DIDN'T RECORD OR REMEMBER WHAT IT WAS. TECHNICAL SUPPORT SME. (B)(4) SUSPECTS THE FAULT MAY HAVE BEEN FAULT 08 OR A HIGH IMPEDANCE FAULT. THE PROVIDER REPORTED THAT THE OTHER AREAS THAT WERE TREATED SHOWED NO ILL EFFECTS OR BURNS. THE PROVIDER ALSO REPORTED THAT THE PATIENT DID HAVE TISSUE ATROPHY, AND THE PURPOSE OF THE TREATMENT WAS AN ATTEMPT OF HOPE THAT THE PROCEDURE WOULD WORK ON THE PATIENT. THE CUSTOMER WAS ASKED TO RETURN THE HANDPIECE USED FOR EVALUATION BECAUSE TESTING ON THE DEVICE WAS NOT DUPLICATED. THE HAND PIECE WAS SENT TO THE MANUFACTURER: PHASE(N) FOR EVALUATION. PHASE(N) INVESTIGATED IN ACCORDANCE WITH DOC#: FQA021-F01 REV:C ROUTER/BOM/INSPECTION SHEET. THE MANUFACTURER CONCLUDED THAT NO PROBLEM WAS FOUND. CUSTOMER WAS SENT A REPLACEMENT DEVICE. FIELD SME, (B)(4) PERFORMED A COURTESY FOLLOW UP CALL AND REVEALED THAT THE USER HAD NOT BEEN TRAINED TO USE THE THERMI DEVICE. THE CUSTOMER WAS SCHEDULED TO COMPLETE TRAINING THE FOLLOWING FRIDAY BUT CHOSE TO ATTEMPT THE PROCEDURE WITHOUT TRAINING. BASED ON THE DETAILS COLLECTED THE ADVERSE EVENT APPEARS TO BE USER-RELATED AND THERE IS NO INDICATION THAT THE THERMI DEVICE WAS THE CULPRIT. EMDR FOLLOW-UP (#001) WAS SUBMITTED 03/28/25 WITH CURRENT DISCUSSION WITH THE CUSTOMER AFTER RECEIVING THE REQUIRED TRAINING AND THEY CONVEYED NO ISSUES USING THE DEVICE. CF CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547688 THERMIVA THERMIVA DWG SPINESMITH HOLDINGS,LLC THERMIVA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other THERMIVA ELECTRODE| THERMIVA ELECTRODE LOT#L23K037