MAUDE Adverse Event Report: ACESSA HEALTH INC. ACESSA PROVU TRANSDUCER WITH SENSOR; COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)

Model Number 7700

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

Patient Problem Abdominal Pain (1685)

Event Date 07/14/2021

Event Type  Injury  

Manufacturer Narrative

The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported and a definitive root cause for the reported event could not be determined.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.Lot and serial number of the device not provided by the complainant; therefore, the unique device identifier, expiration and manufacturing dates are not known.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.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.A such, acessa is making this report only out of an abundance of caution.

Event Description

It was reported that on (b)(6) 2021, during an acessa procedure, the physician performed 2 incisions of 5 mm and 10mm.When entering the cavity, it was observed that there was an unknown amount of fluid, probably from a rupture cyst.The physician performed an ablation of a fibroid, and the array was placed within the bounds of the fibroid.After the ablation there was no bleeding noticed from both entry sites and closed both incisions.The patient was sent to post-op recovery around 330 pm and at 6 pm the patient had a distended stomach.The patient was brought back to the operating room, for a diagnostic laparoscopy.It was reported that the bleeding might came from the 10mm incision site.The patient was reported as stable.No other information is available.

• Brand Name: ACESSA PROVU TRANSDUCER WITH SENSOR
• Type of Device: COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)
• Manufacturer (Section D): ACESSA HEALTH INC.; 317 grace lane; suite #200; austin TX 78746
• Manufacturer (Section G): ACESSA HEALTH INC.; 317 grace lane; suite #200; austin TX 78746
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free zone building b24; san jos?, alajuela 20102- CRI ; CS 20102 CRI
• MDR Report Key: 12319310
• MDR Text Key: 266430414
• Report Number: 3006443171-2021-00003
• 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,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/13/2021

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: 7700
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/15/2021
• Initial Date FDA Received: 08/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ACESSA PROVU CONSOLE; ACESSA PROVU HANDPIECE
• Patient Outcome(s): Hospitalization