MalfunctionHOC
MST
Received Mar 31, 2026
Report 3019924-2026-00081 · MDR key 24746576
Device
Generic name
6.25 Malyugin Ring 2.0 System
Manufacturer
Microsurgical Technology IncModel number
MAL-1001-1Catalog number
MAL-1001-1
Lot number
215956
Product problems
- Difficult to Fold, Unfold or Collapse
Patient
NA · Unknown
- Insufficient Information
Narrative
Description of Event or Problem
ISSUES WITH THE RING BEING "KINKED" PER THE SURGEON, AND NOT ABLE TO BE INSERTED PROPERLY. IT IS TWO OF THEM. ALL HAVE THE SAME LOT NUMBER.
Remedial action
- Replace