BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACESSA PROVU HANDPIECE

    MDR report key: 12775339 · Received November 8, 2021

    Report

    Report Number
    3006443171-2021-00012
    Event Type
    Injury
    Date Received
    November 8, 2021
    Date of Event
    October 4, 2021
    Report Date
    July 18, 2022
    Manufacturer
    ACESSA HEALTH INC.
    Product Code
    HFG
    PMA / PMN Number
    K181124
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    LOT AND SERIAL NUMBER OF THE DEVICE NOT PROVIDED BY THE COMPLAINANT; THEREFORE, THE UDI, EXPIRATION AND MANUFACTURING DATES ARE NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE AS THE IDENTIFICATION NUMBERS WERE NOT PROVIDED BY THE COMPLAINANT. THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED FOR EVALUATION PURPOSES THEREFORE VISUAL AND FUNCTIONAL ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED. WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE DEVICE AND THE ISSUE REPORTED AND A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE INFORMATION OBTAINED DURING COMPLAINT INVESTIGATION WILL BE INCLUDED IN OUR GLOBAL COMPLAINT TRENDING AND PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS TYPE FOR ADVERSE TRENDS. IF THE PRODUCT IS RECEIVED OR ADDITIONAL INFORMATION IS OBTAINED, THE INVESTIGATION WILL BE REOPENED ACCORDINGLY PER STANDARD OPERATING PROCEDURE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION REGARDING THE CASE WAS RECEIVED A PUBLICATION REGARDING ¨POST OPERATIVE UTERINE NECROSIS AND PERITONITIS FOLLOWING LAPAROSCOPIUC RADIOFREQUENCY FIBROID ABLATION ¨ A JOURNAL PRE-PROOF FROM EMILY LIN MD, EMILY SENDUKAS MD, KIMBERLY A. KHO MD, MPH. HTTPS://DOI.ORG/10.1016/J.JMIG.2022.06.006 THE JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY JMIG 4746 S1553-4650(22)00242-4. CITATION : EMILY LIN MD , EMILY SENDUKAS MD , KIMBERLY A. KHO MD, MPH , POSTOPERATIVE UTERINE NECROSIS AND PERITONITIS FOLLOWING LAPAROSCOPIC RADIOFREQUENCY FIBROID ABLATION, THE JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY (2022), DOI: HTTPS://DOI.ORG/10.1016/J.JMIG.2022.06.006. A 49 YEAR-OLD GRAVIDA 1, PARA 0010 UNDERWENT AN UNCOMPLICATED LAPAROSCOPIC ULTRASOUNDGUIDED RADIOFREQUENCY ABLATION OF A SINGLE NON-NECROTIC 10X12CM DOMINANT FUNDAL FIBROID USING THE ACESSA® DEVICE. 5 OVERLAPPING ABLATIONS WERE PERFORMED OVER 16 MINUTES. ON POSTOPERATIVE DAY 9, SHE PRESENTED WITH SEVERE ABDOMINAL PAIN, FEVER, TACHYCARDIA AND HYPOTENSION. ON EXAM, SHE HAD SEVERE UTERINE TENDERNESS, BILATERAL LOWER QUADRANT TENDERNESS AND VOLUNTARY GUARDING. COMPUTED TOMOGRAPHY OF THE ABDOMEN AND PELVIS REVEALED MULTIPLE TRANSMURAL UTERINE SEROSAL DEFECTS, INCLUDING A 3CM DEFECT IN THE MID-ANTERIOR MYOMETRIUM AND A 1.6CM DEFECT IN THE LEFT LATERAL MYOMETRIUM, WITH GAS AND LOW-ATTENUATION MATERIAL TRACKING FROM THE ABLATED FIBROID THROUGH THESE DEFECTS INTO THE PERITONEAL CAVITY, VASOPRESSORS WERE INITIATED DUE TO WORSENING HYPOTENSION AND THE PATIENT WAS EXPEDITIOUSLY TAKEN TO THE OPERATING ROOM FOR AN EXPLORATORY LAPAROTOMY AND HYSTERECTOMY. INTRA-OPERATIVE FINDINGS REVEALED A 22-WEEK SIZED FIBROID UTERUS WITH 4 SEPARATE 1-3CM SEROSAL DEFECTS DRAINING PURULENT MATERIAL. SHE THEN UNDERWENT AN UNCOMPLICATED TOTAL ABDOMINAL HYSTERECTOMY. SHE COMPLETED 48-HOURS OF BROAD-SPECTRUM INTRAVENOUS ANTIBIOTICS POST-OPERATIVELY, THEN TRANSITIONED TO ORAL ANTIBIOTICS. SHE WAS DISCHARGED HOME AFTER MEETING ALL MILESTONES ON POSTOPERATIVE DAY 3. FINAL PATHOLOGY REVEALED EXTENSIVE PYOMETRA. LAPAROSCOPIC RADIOFREQUENCY FIBROID ABLATION VIA THE ACESSA® SYSTEM HAS AN OVERALL LOW COMPLICATION RATE, WITH ONLY 1 PELVIC ABSCESS REPORTED TO-DATE IN A PRE-MARKET PIVOTAL STUDY AND OTHERWISE NO REPORTED CASES OF POST-PROCEDURAL UTERINE INFECTION OR NECROSIS. THIS CASE DEMONSTRATES A PREVIOUSLY UNREPORTED COMPLICATION OF THE ACESSA® PROCEDURE. WHEN PATIENTS PRESENT WITH POST-PROCEDURAL UTERINE NECROSIS, IT IS POSSIBLE FOR RAPID HEMODYNAMIC DETERIORATION TO OCCUR IN THE SETTING OF SEPSIS AND MAY REQUIRE AGGRESSIVE FLUID RESUSCITATION, ADMINISTRATION OF BROAD-SPECTRUM ANTIBIOTICS, VASOPRESSOR SUPPORT AND/OR EMERGENT SURGICAL INTERVENTION. AS MORE PROVIDERS INCORPORATE RADIOFREQUENCY FIBROID ABLATION PROCEDURES INTO THEIR PRACTICE, IT IS IMPORTANT TO RECOGNIZE THE PRESENTATION OF SEVERE UTERINE INFECTION AND NECROSIS TO ENSURE TIMELY DIAGNOSIS AND APPROPRIATE INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT RECEIVED AN ACESSA PROCEDURE ON (B)(6) 2021, AND A FEW DAYS LATER THE PATIENT WAS REPORTED AS SEPTIC AND HAD TO RECEIVE AN EMERGENCY HYSTERECTOMY ON THE LAST WEEK OF OCTOBER. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1673910 ACESSA PROVU HANDPIECE COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES) HFG ACESSA HEALTH INC. 7300

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other ACESSA PROVU CONSOLE.