MalfunctionHCF
M-CLOSE KIT
Received Apr 25, 2025 · Event occurred Mar 19, 2025
Report 21908738 · MDR key 21908738
Device
Generic name
Instrument, Ligature Passing And Knot Tying
Manufacturer
New Wave EndoModel number
27-101Catalog number
27-101
Lot number
L1624
Product problems
- Break
- Device Damaged Prior to Use
Patient
49 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
REPORTED THAT THE DEVICE IS BROKEN/ DEFECTIVE OUT OF PACKAGE.