MAUDE Adverse Event Report: ACESSA HEALTH INC. ACESSA; ACESSA PROVU

Device Problem Use of Device Problem (1670)

Patient Problem Needle Stick/Puncture (2462)

Event Date 10/29/2020

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: ACESSA
• Type of Device: ACESSA PROVU
• Manufacturer (Section D): ACESSA HEALTH INC.; 317 grace ln; suite 200; austin TX 78746
• Manufacturer (Section G): ACESSA HEALTH INC.; 317 grace ln; suite 200; austin TX 78746
• Manufacturer Contact: isaac rodriguez ; 317 grace ln; suite 200; austin, TX 78746 ; 5127850707
• MDR Report Key: 10906106
• MDR Text Key: 218497862
• Report Number: 3006443171-2020-00004
• Device Sequence Number: 1
• Product Code: HFG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2020
• Initial Date FDA Received: 11/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention