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 Problems Abdominal Pain (1685); Fever (1858)

Event Date 12/27/2021

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 after an acessa procedure that took place on (b)(6) 2021 , the patient came back due to developing signs of infection.Patient had onset of pain , fever for four days, was placed on antibiotics but did not improve.Patient received an ultrasound and showed signs of degraded fibroids.Initially the patient was scheduled for a hysterectomy but it was cancelled due that stones were found in the gallbladder and a cholecystectomy was performed.It was reported that the symptoms experienced were due to the stones in her gallbladder and not related to the acessa procedure.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): 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: 13394521
• MDR Text Key: 284702299
• Report Number: 3006443171-2022-00002
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/31/2022

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: 01/14/2022
• Initial Date FDA Received: 01/31/2022
• 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): Hospitalization; Other
• Patient Sex: Female