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

Model Number 210-100

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/21/2023

Event Type  malfunction  

Event Description

While opening surgical supply for procedure in the operating room, staff noted a hole slice approximately 1cm long in the packaging of aveta smol disposable resecting device, 2.9mm.Hole noted prior to adding to surgical field, replaced supply.No procedural delay.

• Brand Name: AVETA SMOL 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: 17876259
• MDR Text Key: 324993473
• Report Number: 17876259
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/21/2023

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 Model Number: 210-100
• Device Catalogue Number: 210-100
• Device Lot Number: F22D16-01
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/21/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1