BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACESSA

    MDR report key: 10906106 · Received November 25, 2020

    Report

    Report Number
    3006443171-2020-00004
    Event Type
    Injury
    Date Received
    November 25, 2020
    Date of Event
    October 29, 2020
    Report Date
    November 23, 2020
    Manufacturer
    ACESSA HEALTH INC.
    Product Code
    HFG
    PMA / PMN Number
    K181124
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS DESCRIBED THROUGH COMMUNICATION WITH THE ACESSA REPRESENTATIVE AND PHYSICIAN, AT NO POINT DURING THE ACESSA PROCEDURE WAS IT OBSERVED THAT A NEEDLE HAD PROTRUDED THROUGH THE POSTERIOR UTERINE WALL AND PUNCTURED THE BLADDER. AS STATED, THE UTERINE MANIPULATOR, WHILE USED DURING THE PROCEDURE, WAS NOT USED WHILE THE NEEDLES WERE DEPLOYED AND ABLATING. THERE WAS NO REPORT OF MALFUNCTION OF ANY COMPONENT OF THE PROVU SYSTEM, INCLUDING THE HANDPIECE. IT IS THEREFORE MOST LIKELY THAT THE INJURY WAS THE RESULT OF MISUSE AND MISPLACEMENT OF THE DEVICE. THE ACESSA PROVU SYSTEM USER'S GUIDE WARNS USERS ON SEVERAL OCCASIONS THAT HANDPIECE PLACEMENT SHOULD BE CONFIRMED WITH ULTRASOUND PRIOR TO THE ACTIVATION OF RF ENERGY, AND THAT THE ELECTRODE NEEDLE ARRAY SHOULD BE FULLY RETRACTED BEFORE POSITIONING, ADVANCING, OR WITHDRAWING THE HANDPIECE. THE ACESSA PROVU SYSTEM USER'S GUIDE ALSO ACKNOWLEDGES THAT DAMAGE TO ADJACENT STRUCTURES IS AN INHERENT RISK FOR RADIOFREQUENCY ABLATION OF FIBROIDS AND IS A COMMON RISK TO ALL SURGICAL PROCEDURES FOR FIBROID TREATMENT. HOWEVER, BASED ON THE INFORMATION PROVIDED THUS FAR THROUGH INVESTIGATION, THERE IS NOTHING TO INDICATE THAT THE INJURY AND SUBSEQUENT REINTERVENTION WERE THE RESULT OF 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 REPRESENTATIVE NOTIFIED OF PATIENT WHO UNDERWENT INTERVENTIONAL BLADDER RESECTION IMMEDIATELY FOLLOWING HER ACESSA PROCEDURE ON (B)(6) 2020. PATIENT PRESENTED FOR HER ACESSA CASE WITH ONE SINGULAR FUNDAL FIBROID ~6 CM. THE ACESSA PROCEDURE CONSISTED OF 10 TOTAL ABLATIONS, THE MAJORITY BEING ANTERIOR, WITH THE LAST 2-3 DIRECTED POSTERIOR AT AN APPROXIMATE 45 DEGREE ANGLE. A UTERINE MANIPULATOR WAS UTILIZED BY THE ATTENDING SCRUB TECH. AFTER THE LAST ABLATION, DURING CLEAN UP, THE ACESSA PHYSICIAN NOTICED BLANCHING OF THE POSTERIOR UTERINE WALL NEAR THE BLADDER. THE BLADDER WAS INSUFFLATED TO CONFIRM BLADDER INJURY. UROLOGIST WAS CALLED IN FOR CYSTOSCOPY, THOUGH NO DAMAGE TO THE BLADDER INTERIOR WAS OBSERVED. THE PATIENT THEN UNDERWENT OPEN SURGERY WITH THE UROLOGIST TO RESECT THE DAMAGED TISSUE ~1-1.5 SQ. INCHES. DURING THE OPEN PORTION OF THE PROCEDURE, A "PIN HOLE", CHARACTERISTIC OF ONE OF THE HANDPIECE NEEDLES, WAS OBSERVED ON THE BLADDER EXTERIOR. FOLLOWING THE INTERVENTION, THE PATIENT WAS EXPECTED TO MAKE A FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369538 ACESSA ACESSA PROVU HFG ACESSA HEALTH INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention