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 12/05/2019

Event Type  Injury  

Manufacturer Narrative

Additional details of the patient's acessa procedure were collected both from the physician and the acessa clinical representative who was in attendance on the date of the case.It was reported that, during placement of the first 5 mm trocar for the laparoscope port, the physician punctured the patient's uterus, causing uncontrolled bleeding in the cavity.The physician attempted to control bleeding during the case, but ultimately the puncture necessitated a hemostatic agent to help control bleeding and allowed for the continuation of the case.The case consisted of treatment of one 6 cm fibroid that was ablated 4 times for a total of 12 minutes.The patient had no issues or preexisting conditions that acessa has been made aware of.No further complications were reported concerning the acessa portion of the case.Lot records for the single-use handpiece show that the handpiece in use was sterilized properly per validated process.All other reprocessed equipment used in the case were also reported to have been sterilized per process.Additionally, all devices in use were reported to have been inspected prior to the case with no sign of abnormalities with the product(s) or product packaging.As no device was collected or returned to acessa as a part of this field complaint, further investigation is limited.Based on the information provided concerning the case in which the acessa procedure was performed, as well as the lot records for the handpiece used, there is nothing to indicate that any component of the acessa provu system would have caused the patient's post-operative infection.However, the uterine puncture prior to the use of acessa and subsequent bleeding may have contributed to this condition.As described in the acessa provu user's guide (pl-01-0040-a), the acessa provu system is intended for use under standard laparoscopy.However, the laparoscope itself, as well as any trocars used to place all equipment ports, are not considered to be a part of the acessa provu system.Therefore, organ puncture is considered to be a risk of general laparoscopic surgery and not an inherent risk of the acessa procedure.As such, acessa is making this report only out of an abundance of caution.

Event Description

Acessa health was notified by a physician on 12/11/2019 that their patient was having complications post-acessa procedure, which was performed on (b)(6) 2019.The physician stated that the patient was re-admitted to the hospital 3 days post-op to treat a suspected infection, identified by an elevated white blood cell (wbc) count.After several rounds of antibiotics were unsuccessful at stabilizing the patient's wbc count, and with the physician fearsome of sepsis, the physician made the decision to perform a hysterectomy, on (b)(6) 2019, to eliminate the source of infection.Patient is reported to be doing well after her hysterectomy, having been discharged from the hospital four days after the procedure with stable blood count.

• Brand Name: ACESSA PROVU HANDPIECE
• Type of Device: ACESSA PROVU
• Manufacturer (Section D): ACESSA HEALTH INC.; 7004 bee cave rd; bldg. 3, suite 200; austin TX 78746
• Manufacturer (Section G): ACESSA HEALTH INC.; 7004 bee cave rd; bldg. 3, suite 200; austin TX 78746
• Manufacturer Contact: isaac rodriguez ; 7004 bee cave rd; bldg. 3, suite 200; austin, TX 78746 ; 5127850707
• MDR Report Key: 9540889
• MDR Text Key: 188486317
• Report Number: 3006443171-2019-00005
• Device Sequence Number: 1
• Product Code: HFG
• UDI-Device Identifier: 00854763006140
• UDI-Public: (01)00854763006140(10)19857867(17)210424
• 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
• Report Date: 12/19/2019

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 Expiration Date: 04/24/2021
• Device Model Number: 7300
• Device Lot Number: 19857867
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 01/02/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention