MAUDE Adverse Event Report: MEDITRINA, INC. AVETA CORAL DISPOSABLE HYSTEROSCOPE; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 214-251

Patient Problem Insufficient Information (4580)

Event Date 07/10/2023

Event Type  malfunction  

Event Description

Camera did not work.Representative present during incident.Hysteroscope removed from field.

• Brand Name: AVETA CORAL DISPOSABLE HYSTEROSCOPE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): MEDITRINA, INC.; 1190 saratoga ave, suite 180; san jose CA 95129
• MDR Report Key: 17442056
• MDR Text Key: 320214059
• Report Number: 17442056
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 00850006759293
• UDI-Public: (01)00850006759293
• 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: 07/12/2023

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: 214-251
• Device Catalogue Number: 214-251
• Device Lot Number: M23A04-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/12/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/02/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1