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 Bowel Burn (1756)

Event Date 12/23/2021

Event Type  Injury  

Event Description

It was reported that during an acessa procedure on (b)(6), the physician accidentally ablated the patient´s colon for 30 seconds while performing an uterine ablation.The patient was admitted to the hospital and a general surgeon was called to assess if the patient would require a colon resection.No other information is available.

Manufacturer Narrative

A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.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.

• 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: 13233007
• MDR Text Key: 283657398
• Report Number: 3006443171-2022-00001
• Device Sequence Number: 1
• Product Code: HFG
• UDI-Device Identifier: 00854763006140
• UDI-Public: (01)00854763006140(10)MOC0000267(17)230827
• 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: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2023
• Device Model Number: 7300
• Device Lot Number: MOC0000267
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2021
• 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; Hospitalization
• Patient Sex: Female