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	06/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Patient to operating room [date redacted] for hysteroscopy, d&c [dilation and curettage], myomectomy.At 1103 it was noted that a piece of metal was present on display inside patient uterus.It was determined that part of the disposable device had broken off inside the patient.1105 charge rn notified.Additional instruments called for to remove the metal object.1112 object removed from patient.Surgical area reviewed for additional fragments and instrumentation likewise inspected.Surgeon confident all fragments removed.Disposable item stored in red bag with patient label and item information sticker on outside.Metal fragment placed in specimen container and also stored.Bag stored in operating room front office by charge rn desk.

• 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: 22456441
• Report Number: 22456441
• Device Sequence Number: 8155660
• Product Code: HIH
• UDI-Device Identifier: 00850006759293
• UDI-Public: (01)00850006759293
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2025
• Report Date (Section F): 06/20/2025

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: M25A15-05
• 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: 07/09/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2025
• 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: 06/20/2025