MAUDE Adverse Event Report: MEDITRINA, INC. AVETA FLEX DISPOSABLE RESECTING DEVICE, 2.9 MM; INSUFFLATOR, HYSTEROSCOPIC

Model Number 210-080

Device Problems Mechanical Problem (1384); Material Separation (1562); Output Problem (3005); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 07/14/2021

Event Type  malfunction  

Event Description

During the course of the hysteroscopy, d&c (dilation and curettage) procedure, the surgeon noticed the aveta flex disposable resecting device was not functioning on the display.The working end of the unit should rotate to perform the resection; however it was "stuck" and not spinning.The device was removed for inspection and on removal, the device came apart in the surgeon's hand.

• Brand Name: AVETA FLEX DISPOSABLE RESECTING DEVICE, 2.9 MM
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): MEDITRINA, INC.; 1190 saratoga ave; suite 180; san jose CA 95129
• MDR Report Key: 12195849
• MDR Text Key: 262496966
• Report Number: 12195849
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 210-080
• Device Catalogue Number: 210-080
• Device Lot Number: F21B02-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/20/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1