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

Model Number 7300

Device Problem Use of Device Problem (1670)

Patient Problem Nerve Damage (1979)

Event Date 06/25/2021

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.The acessa provu system user's guide warns users on several occasions that handpiece placement should be confirmed with ultrasound prior to the activation of radiofrequency energy.The acessa provu system user's guide also 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.However, based on the information provided thus far through investigation, there is nothing to indicate that the injury and subsequent reintervention were the result of 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 Description

It was reported that on (b)(6) 2021, during an acessa procedure, the physician inserted the handpiece too deep and the probe ablated part of the lateral pelvic wall.The patient is experiencing some sensory deficits which are being treated.Additional follow up revealed that the physician mentioned that the patient continues to show improvement each week with the area of deficit now being approximately 8x8x8 cm.The physician diagnosis is neuropraxia.The symptoms from the fibroids have improved.No other information is available.

• Brand Name: ACESSA PROVU HANDPIECE
• 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: 12239446
• MDR Text Key: 263860670
• Report Number: 3006443171-2021-00002
• 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: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/28/2021

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: 7300
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/29/2021
• Initial Date FDA Received: 07/28/2021
• 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
• Treatment: ACESSA PROVU CONSOLE
• Patient Outcome(s): Other