MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY INC MST; MALYUGIN RING 25.0 SYS 6.25

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
The doctor had trouble inserting 2 out of one box and wanted to return all boxes with that lot number.One did not advance, one came out of the injector incorrectly, two leading loop will come out but the other loops are wrapped around each other.No patient injury.

• Brand Name: MST
• Common Device Name: MALYUGIN RING 25.0 SYS 6.25
• 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: 24656343
• Report Number: 3019924-2026-00046
• Device Sequence Number: 20094328
• Product Code: HOC
• UDI-Device Identifier: 00844685006120
• UDI-Public: 00844685006120
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 03/03/2026

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: 214991 216024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 03/20/2026
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown