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

Model Number 7300

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

Patient Problem Abdominal Pain (1685)

Event Date 09/21/2021

Event Type  Injury  

Manufacturer Narrative

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 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.

Event Description

It was reported that a patient received an acessa procedure on september 21st , in which the physician treated in total 8 fibroids , first the physician performed a laparoscopic myomectomy to remove 2 pedunculated fibroids and left a remaining portion for both , then the physician treated 6 fibroids with acessa and tried to find the remaining parts of the previously removed pedunculated fibroids but could not find one after 30 minutes.The physician decided to abort the procedure at this point.The patient was sent to recovery.Later the patient returned to see the physician complaining of pelvic pain and pressure which would aggravate when trying to use the pedal gas on her car and while trying to make a bowel movement.The physician then decided to perform a ct scan which revealed normal results and some free liquid in the pelvic cavity.No other information is available.The status of the patient is unknown.

• 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): ACESSA HEALTH INC.; 317 grace lane; suite #200; austin TX 78746
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free zone building b24; san jose, alajuela 20102- CRI ; CS 20102 CRI
• MDR Report Key: 12686271
• MDR Text Key: 278110946
• Report Number: 3006443171-2021-00009
• 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: 10/22/2021

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: 10/05/2021
• Initial Date FDA Received: 10/22/2021
• 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
• Patient Outcome(s): Other