MAUDE Adverse Event Report: GYRUS ACMI, INC. FLEX-CATCH NT; DISLODGER, STONE, FLEXIBLE

Model Number NT4F19115

Device Problem Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Date 01/10/2023

Event Type  malfunction  

Event Description

Flex catch nt stone device is not working after several uses.Basket not closing.

• Brand Name: FLEX-CATCH NT
• Type of Device: DISLODGER, STONE, FLEXIBLE
• Manufacturer (Section D): GYRUS ACMI, INC.
• MDR Report Key: 16284074
• MDR Text Key: 308824940
• Report Number: MW5114635
• Device Sequence Number: 1
• Product Code: FGO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/12/2023

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: NT4F19115
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1