inforMED
MalfunctionHOC

MST

Received Mar 31, 2026

Report 3019924-2026-00082 · MDR key 24747867

Device

Generic name

6.25 Malyugin Ring 2.0 System

Model number

MAL-1001-1

Catalog number

MAL-1001-1

Lot number

215061 217325

Product problems

  • Difficult to Fold, Unfold or Collapse

Patient

NA · Unknown

  • Insufficient Information

Narrative

Description of Event or Problem

DID NOT DEPLOYED CORRECTLY AND RING DEFECTED. NO PATIENT INJURY.

Remedial action

  • Replace