inforMED
MalfunctionHCF

M-CLOSE KIT

Received Feb 25, 2026 · Event occurred Jan 5, 2026

Report 24442245 · MDR key 24442245

Device

Generic name

Instrument, Ligature Passing And Knot Tying

Manufacturer

New Wave Endo

Model number

27-101

Catalog number

27-101

Lot number

A0926

Patient

22 YR · Male

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

WHILE USING THE M-CLOSE DEVICE, IT WAS NOTICED THAT PART OF IT, SPECIFICALLY THE LOOP WIRE, WAS MISSING. CT AND X-RAY WERE COMPLETED ON THE PATIENT, NEGATIVE FOR FOREIGN BODY.