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

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
The first would not open up properly and was unshaped so that it could not attach to iris.- patient contact.No injury the 2nd one of the rings was bent and would not unfurl.Noticed before entering patient eye.No patient contacts. .

• Brand Name: MST
• Common Device Name: MALYUGIN RING SYSTEM 2.0 7.0
• Manufacturer (Section D): MICROSURGICAL TECHNOLOGY INC; 84150154th ave ne; redmond WA 98052
• Manufacturer (Section G): MICROSURGICAL TECHNOLOGY INC; 84150154th ave ne; redmond WA 98052
• Manufacturer Contact: yamini nidumolu ; 84150154th ave ne; redmond, WA 98052 ; 4255560544
• MDR Report Key: 23723505
• Report Number: 3019924-2025-00038
• Device Sequence Number: 13424389
• Product Code: HOC
• UDI-Device Identifier: 00844685006137
• UDI-Public: 00844685006137
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 12/04/2025

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
• Device Lot Number: 212405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown