MAUDE Adverse Event Report: MEDITRINA INC. AVETA CONTROLLER

Model Number 212-080

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Air Embolism (1697)

Event Date 04/24/2023

Event Type  Injury  

Event Description

Per surgeon and room staff: after resection was complete, the physician noticed a large air bubble in the cavity.Immediately following, the physician saw an error message on the screen stating a "pump motor error" and the fluid management accessory (fma) unlocked.The physician removed the scope, the circulator relocked the fma, and the physician primed the scope again.The physician then went back into the cavity to clear the air bubbles and take a post resection picture, at which point the patient coded.The scope was removed again and patient tended to and is stable.

Manufacturer Narrative

The aveta system used in the reported event was not returned to meditrina for investigation.However, the system, including the aveta controller s/n (b)(4), aveta pearl hysteroscope, aveta fluid management accessory, and the aveta smol disposable resecting device used in the reported procedure were inspected by the meditrina representative at the user site following the reported event.During the follow-up inspection and functional testing of the aveta controller s/n (b)(4), the reported mode of the failure (i.E."pump motor error" notification and opening of the cassette) could not be replicated.There was no system malfunction, nor were there air bubbles at any point in the irrigation line.In the follow-up testing, the controller met all specifications, except for the controller speaker, which was nonfunctional.The speaker function is a redundant notification to the user after the primary notification on the overhead display and is not related to the reported event.Additional testing of the pump did not show signs of damage or sensor malfunction.The "pump motor error" and opening of the cassette described during the procedure could not be repeated.Additional testing is required by the meditrina team to further investigate the cause of the "pump motor error" and could not be completed at the user facility.Although the "pump motor error" failure could not be replicated in the follow-up inspection, if a "pump motor error" does occur, the controller pump opens automatically, and siphons all saline out of the uterus.At this point the system is in a safe standby mode and cannot introduce saline nor air into the uterine cavity and introduces no risk to the patient.The aveta fluid management accessory used in the procedure was also visually inspected for damage that could breach the surface of the irrigation line and potentially pull air into the tubing.No visible breach could be found, however, the additional saline spike that was not used during the procedure had saline in the line and inside the spike cap, indicating that it had remained opened at some point during the procedure.With irrigation running, this open clamp potentially can allow variable amounts of air in the system and then into the patient.The aveta system user manual ifu-200-1202 states that unused saline spike must be clamped (closed).

• Brand Name: AVETA CONTROLLER
• Type of Device: AVETA CONTROLLER
• Manufacturer (Section D): MEDITRINA INC.; 1190 saratoga ave, suite 180; san jose CA 95129
• Manufacturer (Section G): MEDITRINA INC; 1190 saratoga ave. suite 180sa; san jose CA 95129
• Manufacturer Contact: lyudmila kokish ; 1190 saratoga ave suite 180; san jose, CA 95129 ; 4085192692
• MDR Report Key: 16857310
• MDR Text Key: 314443596
• Report Number: 3015512350-2023-00007
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/02/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 212-080
• Device Catalogue Number: 212-080
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/24/2023
• Initial Date FDA Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Female