MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY INC MST; 6.25 MALYUGIN RING 2.0 SYSTEM

Model Number	MAL-1001-1
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
Dr.(b)(6) attempted to use two different malyugin rings from the same box (information above).He was unsuccessful at delivering the ring as it was twisted in the delivery.The front ring would deploy but the second two are twisted together.He attempted to untwist it with a second instrument but was unsuccessful.No patient injury.

• Brand Name: MST
• Common Device Name: 6.25 MALYUGIN RING 2.0 SYSTEM
• 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: 24737209
• Report Number: 3019924-2026-00076
• Device Sequence Number: 15763637
• Product Code: HOC
• UDI-Device Identifier: 00844685006120
• UDI-Public: 00844685006120
• Combination Product (Y/N): N
• 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: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/30/2026

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: MAL-1001-1
• Device Catalogue Number: MAL-1001-1
• Device Lot Number: 214283
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown