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

Model Number 214-251

Device Problem No Display/Image (1183)

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

Event Date 06/22/2023

Event Type  malfunction  

Event Description

Dnc (dilation and curettage) was ongoing with hystereroscopy.During the case, the scope for aveta (coral disposable hysteroscpe 4.6mm ref# 214-251, lot# m22l21-01) per the surgeon the image flipped on the screen and the screen turned black.No image seen on the screen.Troubleshooting done with the vendor.The scope was replaced and the image on the screen came back.The case finished.Charge nurse informed of the incident.The product bagged and placed in charge nurse office.

• 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: 17305432
• MDR Text Key: 318849135
• Report Number: 17305432
• Device Sequence Number: 1
• Product Code: HIH
• 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: 06/23/2023,06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 214-251
• Device Catalogue Number: 214-251
• Device Lot Number: M22L21-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/23/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20440 DA
• Patient Race: White