MalfunctionHOC
MST
Received Mar 31, 2026
Report 3019924-2026-00079 · MDR key 24746020
Device
Generic name
Malyugin Ring 2.0 Sys 7.0 Malyugin Ring 2.0 Sys 6.25
Manufacturer
Microsurgical Technology IncModel number
MAL-1002-1 MAL-1001-1Lot number
216592 213970
Product problems
- Difficult to Fold, Unfold or Collapse
Patient
NA · Unknown
- Insufficient Information
Narrative
Description of Event or Problem
THE CUSTOMER FILED A MEDSUN REPORT (B)(4)TO FDA, THE REPORT STATES: THE MALYUGIN RING WAS OPENED FOR USE. HOWEVER, THE SURGEON NOTICED THE RING WAS NOT CORRECTLY ANGLED/DEFECTIVE WHEN DEPLOYED FOR USE. ANOTHER MALYUGIN RING WAS OPENED AND THE SURGEON NOTICED THE SAME ISSUE. PER THE TEAM, MATERIAL OF THE RING WAS CHANGED IN 2.0 VERSION. NO PATIENT INJURY REPORTED.
Remedial action
- Replace