BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOLASER X4

    MDR report key: 19873283 · Received July 31, 2024

    Report

    Report Number
    3001431138-2024-00013
    Event Type
    Injury
    Date Received
    July 31, 2024
    Date of Event
    May 20, 2024
    Report Date
    August 1, 2024
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K213594
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL DEVICE INVOLVED IN THE EVENT WAS AT THE CLINIC AS A DEMO DEVICE THAT WAS RETURNED TO ELESTA IN JUNE 2024. FOLLOWING THE RETURN OF THE DEVICE IT HAS BEEN INSPECTED AND FOUND WORKING PROPERLY WITHIN SPECIFICATIONS (SERVICE REPORT CASE ID # (B)(4). THE TECHNICIAN FOUND THE DEVICE WORKING PROPERLY WITHIN SPECIFICATION. ALL THE AVAILABLE INFORMATION RELATIVE TO THE CASE HAS BEEN SHARED WITH THE CRP DEPARTMENT IN ORDER TO HAVE A CLINICAL EVALUATION OF THE EVENT. ELESTA CLINICALS, IN COOPERATION WITH EL.EN. CLINICALS, HAVE PERFORMED THE INVESTIGATION AND SPECIFIED ALL THE INFORMATION RELATIVE TO THE EVALUATION. SPECIFICALLY IT IS REPORTED: THE PATIENT UNDERWENT A TREATMENT OF TRANSPERINEAL-PROSTATE-LASER-ABLATION DUE TO BENIGN PROSTATIC HYPERTROPHY (BPH) ASSOCIATED WITH URINARY TRACT SYMPTOMATOLOGY. THE PROSTATIC ABSCESS REPORTED BY THE PATIENT IS A WELL-KNOWN COMPLICATION OF THE BPH TREATMENT (IN THE APPLICABLE LITERATURE THIS SIDE EFFECT IS ESTIMATED IN THE 4.8% OF THE CASES). THE CAUSE OF THE ABSCESS CREATION IS RELATIVE TO THE BACTERIAL INFECTION ON THE SITE WHERE THE ABLATION IS PERFORMED. IN ORDER TO AVOID SUCH EVENT AN ANTIBIOTIC THERAPY IS PERFORMED ON THE PATIENT FROM ONE DAY PRIOR TO THE TREATMENT UP TO FIVE DAYS FOLLOWING THE TREATMENT. IT IS REPORTED BY THE PHYSICIAN THAT THIS THERAPY HAS BEEN PERFORMED ON THE PATIENT. DESPITE THIS PRECAUTION BACTERIA CAN STILL BE PRESENT ON THE PATIENT'S PROSTATE AND CAUSE AN INFECTION ON THE ABLATED AREA GENERATING THE ABOVE MENTIONED ABSCESS. AS PRESENT IN THE APPLICABLE LITERATURE THE TURP INTERVENTION, FORESEEN ON THE PATIENT IN ORDER TO REMOVE THE ABSCESS, IS CONSIDERED THE GOLD STANDARD FOR BPH TREATMENT. ABSCESSES ARE A FORESEEABLE SIDE EFFECT OF THE TREATMENT WITH THE DEVICE ESCHOLASEX X4, AS AN EVOLUTION OF THE COLLIQUATION OF THE TREATMENT AREA, AT CHAPTER "ADVERSE EFFECT" OF THE OPERATOR'S MANUAL CODE OM095A1-C1-E1-F1_I.V23 (ACTUAL REVISION SHIPPED WITH THE DEVICE). BASED ON WHAT STATED ABOVE IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT, FOR WHICH IT IS CONSIDERED THAT THE ADVERSE EVENT TOOK PLACE WITHOUT ANY SPECIFIC CORRELATION WITH THE DEVICE AND ITS USE. DUE TO THE FACT THAT NO DIRECT CORRELATION BETWEEN THE EVENT, THE MEDICAL DEVICE INVOLVED IN THE EVENT AND ITS USE, HAS BEEN DETERMINED THE PRESENT EVENT HAVE NO IMPACT ON THE RISK MANAGEMENT FILE OF THE DEVICE THAT WILL BE CONSIDERED STILL ADEQUATE.

    Description of Event or Problem · 0

    IN DATE 15/07/2024 WE RECEIVE A COMMUNICATION FROM ELESTA SPA (WORLDWIDE DISTRIBUTOR) OF AND ADVERSE EVENT IN WHICH A PATIENT REQUIRED HOSPITALIZATION FOLLOWING A LASER TREATMENT WITH THE DEVICE ECHOLASER X4. IN THE NARRATIVE PROVIDED IS REPORTED THE FOLLOWING: IN DATE (B)(6) 2024 DR. (B)(6) (THE PHYSICIAN WHO PERFORMED THE TREATMENT) INFORMED VIA MESSAGES THAT THE PATIENT TREATED IN DATE (B)(6) 2024 HAS BEEN HOSPITALIZED IN ER DUE TO AN ABSCESS ON THE RIGHT PROSTATIC LOBE, THAT REQUIRES DRAINING, WHILE THE LEFT PROSTATIC LOBE HAS BEEN FOUND WELL TREATED. IN FOLLOWING COMMUNICATION, THE PHYSICIAN, REPORTED THAT IN DATE (B)(6) 2024 HAS BEEN DISCHARGED FROM THE HOSPITAL FOLLOWING A LONG-LASTING INTRAVENOUS ANTIBIOTIC THERAPY. THE PATIENT WILL BE KEPT UNDER ANTIBIOTIC THERAPY FOR ANOTHER MONTH WHILE AWAITING TURP SURGERY (GOLSD STANDARD FOR BENIGN PROSTATIC HYPERTROPHY). THE ACTUAL DEVICE INVOLVED IN THE EVEN WAS AT THE CLINIC AS A DEMO DEVICE THAT WAS RETURNED TO ELESTA IN JUNE 2024. FOLLOWING THE RETURN OF THE DEVICE IT HAS BEEN INSPECTED AND FOUND WORKING PROPERLY WITHIN SPECIFICATIONS (SERVICE REPORT CASE ID # (B)(4). THE PRESENT ADVERSE EVENT HAS BEEN EVALUATED AS A REPORTABLE, IN ACCORDANCE WITH US FDA 21 CFR PART 803 BECAUSE THE PATIENT HAS BEEN HOSPITALIZED FOLLOWING THE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983311 ECHOLASER X4 ECHOLASER X4 GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M095C1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization