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

Model Number	214-251
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Video was going in and out.Healthcare provider tried plugging the device back into aveta machine and did not work.Healthcare provider had to open a new aveta hysteroscope.

• Brand Name: AVETA CORAL DISPOSABLE HYSTEROSCOPE
• Common Device Name: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): MEDITRINA, INC.; 1190 saratoga ave suite 180; san jose CA 95129
• MDR Report Key: 18449591
• Report Number: 18449591
• Device Sequence Number: 6949830
• Product Code: HIH
• UDI-Device Identifier: 00850006759293
• UDI-Public: (01)00850006759293
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 11/06/2023
• Report Date (Section F): 11/06/2023

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
• Operator of Device: Health Professional
• Device Model Number: 214-251
• Device Catalogue Number: 214-251
• Device Lot Number: M23D18-02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/05/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/06/2023