BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACESSA

    MDR report key: 10702352 · Received October 19, 2020

    Report

    Report Number
    3006443171-2020-00003
    Event Type
    Injury
    Date Received
    October 19, 2020
    Date of Event
    September 18, 2020
    Report Date
    October 14, 2020
    Manufacturer
    ACESSA HEALTH INC.
    Product Code
    HFG
    UDI-DI
    00854763006232
    PMA / PMN Number
    K181124
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS DESCRIBED THROUGH COMMUNICATION WITH THE ACESSA PHYSICIAN, THE ACESSA CASE WAS UNREMARKABLE, AND WAS COMPLETED WITHOUT ANY ABNORMALITIES OR OBSERVATIONS OF DEVICE MALFUNCTION. THE OPERATING ACESSA PHYSICIAN HAS PERFORMED MANY ACESSA CASES SINCE COMPLETING HER PROCTORED TRAINING IN 2016 AND COMMENTED THAT THEY ARE ALWAYS VERY CAREFUL WITH THE ACESSA PROCEDURE. THIS PARTICULAR PATIENT'S UTERUS WAS VERY ENLARGED AND 12 FIBROIDS OF VARIOUS SIZES AND LOCATIONS WERE TREATED. THE ACESSA PHYSICIAN DID NOT OBSERVE ANY FACTORS THAT COULD HAVE CONTRIBUTED TO UNINTENDED CONDUCTIVITY TO SURROUNDING STRUCTURES (METAL IMPLANTS, ADHESIONS, EXCESSIVE FLUID, ETC.) AND THE PATIENT WAS CONSIDERED BY THE PHYSICIAN TO BE AN ACCEPTABLE CANDIDATE FOR THE ACESSA PROCEDURE. THE ACESSA PROVU SYSTEM USER'S GUIDE ACKNOWLEDGES THAT DAMAGE TO ADJACENT STRUCTURES IS AN INHERENT RISK FOR RADIOFREQUENCY ABLATION OF FIBROIDS AND IS A COMMON RISK TO ALL SURGICAL PROCEDURE FOR FIBROID TREATMENT. HOWEVER, BASED ON THE INFORMATION PROVIDED THUS FAR THROUGH INVESTIGATION, THERE IS NOTHING TO INDICATE THAT THE PATIENT'S SYMPTOMATIC CLAIMS AND SUBSEQUENT REINTERVENTION WERE DUE TO A MALFUNCTION OR DEFICIENCY IN THE MANUFACTURING, DESIGN, OR LABELING OF THE ACESSA PROVU SYSTEM. ACESSA WILL SUBMIT A SUPPLEMENTAL REPORT SHOULD ADDITIONAL INFORMATION BE MADE AVAILABLE.

    Description of Event or Problem · 1

    ACESSA PHYSICIAN NOTIFIED ACESSA REPRESENTATIVE THAT A PATIENT WHO HAD UNDERWENT THE ACESSA PROCEDURE ON (B)(6) 2020 HAD BEEN ADMITTED TO THE ICU POST-OPERATIVELY ON (B)(6) 2020. REPORTEDLY, THE PATIENT HAD COMPLAINED OF SEVERE PAIN BEFORE SHE WAS DISCHARGED FROM HER ACESSA PROCEDURE AND HAD ALSO CALLED THE ACESSA PHYSICIAN OVER THE FOLLOWING WEEKEND COMPLAINING OF PAIN. ON POST-OP DAY 4, WITH THE PATIENT ALSO COMPLAINING OF BLOATING, THE ACESSA PHYSICIAN SENT THE PATIENT IN TO BE EVALUATED. AS REPORTED BY THE ACESSA PHYSICIAN, THE PATIENT UNDERWENT BOWEL SURGERY TO REPAIR HER BOWEL FROM SUSPECTED BURN DAMAGE. THE PATIENT IS CURRENTLY ON ANTIBIOTICS AND IS RECOVERING SLOWLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1159913 ACESSA ACESSA PROVU HFG ACESSA HEALTH INC. 7100 00854763006232

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention