BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARVATI

    MDR report key: 18167259 · Received November 19, 2023

    Report

    Report Number
    3006404071-2023-00003
    Event Type
    Injury
    Date Received
    November 19, 2023
    Date of Event
    March 2, 2021
    Report Date
    November 19, 2023
    Manufacturer
    SPINESMITH HOLDINGS,LLC
    Product Code
    DWG
    UDI-DI
    00817771029068
    PMA / PMN Number
    K130689
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL COMPLAINT WAS OPENED ON 03/02/2021 AFTER INVESTIGATION, IT WAS DECIDED THAT THIS WAS A NON-REPORTABLE EVENT. DURING 2023 FDA AUDIT, INSPECTOR INDICATED THAT THE COMPLAINT REQUIRED RE-ASSESSMENT. COMPLAINT CASE WAS RE-OPENED ON 08/04/23 FOR ASSESSMENT AND FOR APPROPRIATE REPORTING ACTIVITIES.

    Description of Event or Problem · 0

    PHYSICIAN REPORTED TO SALES REPRESENTATIVE ON (B)(6) 2021 THAT DURING THE THERMISMOOTH PROCEDURE THE PATIENT COMPLAINED OF A SPARKING AND BURNING SENSATION. PHYSICAN REPORTED THAT HE HAD PICTURES BUT THEY WERE NEVER OBTAINED DURING THE INITIAL CALL BACK ON (B)(6) 2021. PHYSICIAN DID REPORT THAT DURING SETUP HE HAD TO PUSH THE ELECTRODE INTO THE GENERATOR VERY HARD. PHYSICIAN REQUESTED THAT THE GENERATOR AND ELECTRODE BE EVALUATED. FOLLOW UP CALL ON (B)(6) 2021 BY THEN QUALITY MANAGER FOR SPINESMITH, COLLECTED THAT THERE WAS A MAXIMUM SKIN TEMP OF 45.5C FROM THE FLIR CAMERA, THE TREATMENT LASTED 10 MINUTES, PHYSICIAN REPORTED NO PROBLEMS DURING THE TREATMENT. CUSTOMER ACCOUNT NOTES THAT A 2ND TREATMENT WAS PERFORMED THE PATIENT OVER A BIGGER AREA (CROW'S FEET AND CHEEKBONES), PATIENT COMPLAINED AT 2ND TREATMENT AS WELL. ON (B)(6) 2023 ARVATI SN# (B)(6) AND ELECTRODES RFE-10-D-G2 SN# (B)(6) AND RFE-15-D-G2 SN# (B)(6) WERE SENT IN FOR INVESTIGATION. INSPECTION AND TESTING OF CUSTOMER OWNED GENERATOR SHOWED THAT ACTIVE RF PERFORMED FOR 1HR WITH SET TEMPERATURE OF 90C, IMPEDANCE LEVELS, TEMPERATURE RESPONSE AND SAFETY TESTING ALL TESTINGED WITHIN EXPECTED PARAMETERS. THERE WERE NOT ANOMALIES OR FAILURES OBSERVED BY SERVICE PERSONNEL. RFE ELECTRODES WERE SENT TO THE MANUFACTURER (PHASE(N) CORP) AND EVALUATION SHOWED NO PROBLEMS WERE OBSERVED OR REPORTED. CASE WAS CLOSED ON 07/21/21. COMPLAINT WAS RE-OPENED ON 08/04/2023 FOR RE-ASSESSMENT IN RESPONSE TO 2023 FDA AUDIT. ATTEMPTS HAVE BEEN MADE TO CONTACT THE OFFICE ON 08/08/23, 08/18/23 AND 08/22/23. NO REPONSE AS OF 11.19.23, HOWEVER PHYSICIAN DID PURCHASE EXTENDED WARRANTY IN 03/2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673476 ARVATI THERMI RF GENERATOR DWG SPINESMITH HOLDINGS,LLC G2 00817771029068

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other #2130AC GROUNDING PAD| RFE-10-D-G2 ELECTRODE| RFE-15-D-G2 ELECTRODE