MalfunctionHCF
M-CLOSE KIT
Received Aug 15, 2025 · Event occurred Jul 31, 2025
Report 22814542 · MDR key 22814542
Device
Generic name
Instrument, Ligature Passing And Knot Tying
Manufacturer
New Wave EndoModel number
27-101Catalog number
27-101
Lot number
B0725
Product problems
- Activation Failure
Patient
18 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE DEVICE WOULD NOT COMPLETE THE SECOND CLICK TO COMPLETE THE CLOSURE.