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

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

Patient Problem Organ Dehiscence (2502)

Event Date 06/24/2021

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 udi, 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.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 procedures for fibroid treatment.Multiple attempts have been made with the initial reporter and no further information has been received regarding the event.The root cause of the injury is unknown.Based on the information provided thus far through investigation, there is no evidence that the injury was the result of a malfunction or deficiency in the manufacturing, design, or labeling of the acessa provu system.A report was submitted out of an abundance of caution.Acessa will submit a supplemental report should additional information be made available.

Event Description

It was reported that on (b)(6) 2021, a patient suffered a ruptured uterus during a pregnancy of unknown gestational age, the patient had received a previous myomectomy with an acessa system, on an unknown date.

• Brand Name: ACESSA PROVU SYSTEM
• 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): HOLOGIC, INC.; 250 campus drive; marlborough, MA 01752
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free zone building b24; san jos[?], alajuela 20102- CRI ; CS 20102 CRI
• MDR Report Key: 12218553
• MDR Text Key: 263462169
• Report Number: 3006443171-2021-00001
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/23/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2021
• Initial Date FDA Received: 07/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention