MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY INC MST; MALYUGIN RING SYSTEM 2.0 7.0MM

Model Number	MAL-1002-1
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Experienced a failure with one of the m.Ring 7.0mm injectors from our recent box, where the injector did not deploy and instead curled within the cavity.This disrupted the procedure, and we believe the product may have been faulty.Mr used as per dfu - surgeon is experienced.Opened a new malyugin ring (6.25) as the complaint sample is the last in the box.No patient injury.

• Brand Name: MST
• Common Device Name: MALYUGIN RING SYSTEM 2.0 7.0MM
• Manufacturer (Section D): MICROSURGICAL TECHNOLOGY INC; 8415 154th ave ne; redmond WA 98052
• Manufacturer (Section G): MICROSURGICAL TECHNOLOGY INC; 8415 154th ave ne; redmond WA 98052
• Manufacturer Contact: yamini nidumolu ; 8415 154th ave ne; redmond, WA 98052 ; 4255560544
• MDR Report Key: 23589588
• Report Number: 3019924-2025-00028
• Device Sequence Number: 10233468
• Product Code: HOC
• UDI-Device Identifier: 00844685006137
• UDI-Public: 00844685006137
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/18/2025

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
• Device Model Number: MAL-1002-1
• Device Catalogue Number: MAL-1002-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown