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

Model Number 7300

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 01/10/2020

Event Type  Injury  

Manufacturer Narrative

Identified during a physician's round table discussion that occurred after the procedure, was reported by an acessa rep attendee that heard the discussion.Physician indicated that the patient was fine post-op, two weeks later presented with low-grade fever and uti.Was admitted to hospital and treated for a few days with iv antibiotics.The physician did not return a device to acessa, nor did he report any device lot number or udi, thereby limiting further device investigation by acessa.Feedback from the operating physician was collected as part of acessa's investigation.According to the physician, there were no perceived deficiencies with any acessa products or packaging prior to the case and there were no perceived deficiencies with sterile processing of any acessa devices prior to the case.The physician did not report any abnormalities or unusual event that took place during the case, simply noting that, during one fibroid treatment, the ablation was discontinued after about 20 seconds after the physician was unsatisfied with his placement of the location of the ablation zone.This did not lead to any complication of the case.The physician expanded on his initial report, stating that the patient was admitted with symptoms of high temperature and malaise.The patient's white blood cell count was elevated at 15.7.She was placed on iv antibiotics and hospitalized for five days.The physician reported the most up-to-date status of the patient, that on (b)(6) 2020 she stated that she is feeling well and feels excellent resolution of her symptoms.She did report of some bothersome vaginal discharge but agreed upon a timeline of observation with the physician.Review of the acessa provu user's guide (pl-00-0040-b), with clinical data, details that post-operative infection and vaginal discharge are both potential risks of the acessa procedure.However, based on the information provided thus far in the investigation, there is nothing to indicate that the patient's symptomatic claims were due to a malfunction or deficiency in manufacturing, design, or labeling of the acessa provu system.Furthermore, the performance of a concomitant myomectomy of one fibroid introduces additional equipment and operative risks that are not in scope of the acessa procedure.Acessa will submit a supplemental report should additional information be made available.

Event Description

On an acessa physician group call on (b)(6) 2020, one physician presented an event regarding a patient who had had the acessa procedure on (b)(6) 2020.The case was presented for group discussion in an acessa forum with feedback from fellow acessa physicians, specifically one physician, the inventor of the procedure and subject matter expert.The patient being presented had 8 fibroids treated in her case with acessa rf ablation, with one exophytic fibroid removed concomitantly by laparoscopic myomectomy.The patient was treated with prophylactic antibiotics.However, two weeks later, the patient developed a low-grade fever and uti.Imaging also showed the presence of gas build up in the patient's myometrium.The patient was admitted to the hospital and treated with iv antibiotics, after which she saw resolution.

• Brand Name: ACESSA PROVU HANDPIECE
• Type of Device: ACESSA PROVU
• Manufacturer (Section D): ACESSA HEALTH INC.; 317 grace ln; suite 200; austin, tx
• Manufacturer (Section G): ACESSA HEALTH INC.; 317 grace ln; suite 200; austin, tx
• Manufacturer Contact: isaac rodriguez ; 317 grace ln; suite 200; austin, tx ; 7850707
• MDR Report Key: 10075863
• MDR Text Key: 195567146
• Report Number: 3006443171-2020-00002
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial

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
• Device Model Number: 7300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2020
• Initial Date FDA Received: 05/20/2020
• 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): Hospitalization; Required Intervention