MAUDE Adverse Event Report: MEDITRINA INC. AVETA MAX+ DISPOSABLE RESECTING DEVICE, 3.9MM; Insufflator, hysteroscopic

Model Number 210-2013

Device Problem Use of Device Problem (1670)

Patient Problem Uterine Perforation (2121)

Event Date 03/22/2024

Event Type  Injury  

Manufacturer Narrative

The reported complaint was reviewed and the returned aveta max+ disposable resecting devices (max+ drd) lot # f23k12-01 (qty 2) were investigated.Based on the investigation and visual inspection, it was observed that tissue was stuck between the resecting teeth causing the resecting tips to not rotate as intended.Both the devices were tested for rotation both manually and through the controller.The devices were found to be functioning as intended.The poor visualization and rising fluid deficit was due to excessive fluid in the uterine cavity due to the perforation.Based on the location of the perforation (perforation in lateral uterine wall and uterine artery damage), the aveta resecting devices cannot reach to this location and the injury caused is therefore considered not as a result of device malfunction.Based on the event summary of the reported complaint and the investigation performed on the returned devices, it is unclear if meditrina devices contributed to the reported adverse event.Meditrina sales rep then followed up with the medical staff member at the facility who stated that the patient was taken to the hospital following the procedure and was found to have a large amount of blood in the abdomen.Perforation was noticed in lateral uterine wall and uterine artery damage was noted.The patient was treated in the hospital/or.Upon further follow up, it was stated that the patient was discharged home and was doing fine.

Event Description

It was reported that the physician was treating the patient with a large fibroid and started resection using aveta max+ disposable resecting device (max+ drd) lot # f23k12-01.During resection, the max+ drd stopped working after roughly 15 seconds into resection.The first max+ drd was replaced with second max+ drd from same lot # f23k12-01 and again drd stopped working shortly after starting resection.The physician then attempted using an aveta flex+ disposable resecting device lot # unknown and decided to stop shortly after due to poor visualization and rising fluid deficit.It was reported that the anesthesiologist and the physician started conversing further about the patients' vitals and decided they needed to transport the patient to the hospital to treat the perforation in the lateral uterine wall.

• Brand Name: AVETA MAX+ DISPOSABLE RESECTING DEVICE, 3.9MM
• Type of Device: Insufflator, hysteroscopic
• Manufacturer (Section D): MEDITRINA INC.; 1190 saratoga ave, suite 180; san jose CA 95129
• Manufacturer (Section G): MEDITRINA INC; 1190 saratoga ave. suite 180; san jose CA 95129
• Manufacturer Contact: lyudmila kokish ; 1190 saratoga ave suite 180; san jose, CA 95129 ; 4085192692
• MDR Report Key: 19147703
• MDR Text Key: 340675203
• Report Number: 3015512350-2024-00001
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213171
• 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: 04/19/2024

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: 210-2013
• Device Catalogue Number: 210-2013
• Device Lot Number: F23K12-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2023
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female