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

Model Number	7100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bowel Burn (1756)
Date of Event	09/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As described through communication with the acessa physician, the acessa case was unremarkable, and was completed without any abnormalities or observations of device malfunction.The operating acessa physician has performed many acessa cases since completing her proctored training in 2016 and commented that they are always very careful with the acessa procedure.This particular patient's uterus was very enlarged and 12 fibroids of various sizes and locations were treated.The acessa physician did not observe any factors that could have contributed to unintended conductivity to surrounding structures (metal implants, adhesions, excessive fluid, etc.) and the patient was considered by the physician to be an acceptable candidate for the acessa procedure.The acessa provu system user's guide acknowledges that damage to adjacent structures is an inherent risk for radiofrequency ablation of fibroids and is a common risk to all surgical procedure for fibroid treatment.However, based on the information provided thus far through investigation, there is nothing to indicate that the patient's symptomatic claims and subsequent reintervention were due to 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 or Problem Description
Acessa physician notified acessa representative that a patient who had underwent the acessa procedure on (b)(6) 2020 had been admitted to the icu post-operatively on (b)(6) 2020.Reportedly, the patient had complained of severe pain before she was discharged from her acessa procedure and had also called the acessa physician over the following weekend complaining of pain.On post-op day 4, with the patient also complaining of bloating, the acessa physician sent the patient in to be evaluated.As reported by the acessa physician, the patient underwent bowel surgery to repair her bowel from suspected burn damage.The patient is currently on antibiotics and is recovering slowly.

• Brand Name: ACESSA
• Common Device Name: ACESSA PROVU
• Manufacturer (Section D): ACESSA HEALTH INC.; 317 grace ln; suite 200; austin TX 78746
• MDR Report Key: 10702352
• Report Number: 3006443171-2020-00003
• Device Sequence Number: 19117341
• Product Code: HFG
• UDI-Device Identifier: 00854763006232
• UDI-Public: (01)00854763006232(11)181129
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K181124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/14/2020

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
• Operator of Device: Health Professional
• Device Model Number: 7100
• Device Catalogue Number: 7100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 10/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention