InjuryOXC
NEOVEIL
Received May 31, 2026 · Event occurred Jan 30, 2026
Report 3012602431-2026-00046 · MDR key 25344872
Device
Generic name
Mesh, Surgical, Absorbable, Staple Line Reinforcement, Product Code: Oxc
Manufacturer
Gunze LimitedModel number
NV-ET-M60A-2Catalog number
NV-ET-M60A-2
Product problems
- Material Integrity Problem
Patient
NA · Unknown
- Foreign Body In Patient
- Insufficient Information
Narrative
Description of Event or Problem
A CUSTOMERS USES NEOVEIL TUBES IN BARIATRIC SURGERY. HE RECENTLY TESTED REFERENCE NV-ET-M60A-2 WITH GOLD PANTHER STAPLERS CADF-60S (GOLD). DURING STAPLING, A WIRE BROKE, AND ONE OF THE WHITE PARTS REMAINED SEWN TO THE BLUE PART. THE SURGEON CUT THE WHITE PART TO REMOVE IT, BUT A SMALL FRAGMENT WAS LEFT IN THE PATIENT. BASED ON OUR OBSERVATIONS, THIS ISSUE MAY BE DUE TO A CERTAIN FRAGILITY OF THE NV TUBE WIRES.