NEOVEIL
Received Mar 16, 2026 · Event occurred Jan 30, 2026
Report 3010668881-2026-00001 · MDR key 24605039
Device
Generic name
Mesh, Surgical, Absorbable, Staple Line Reinforcement
Manufacturer
Gunze LimitedModel number
NV-ET-M60A-2Catalog number
NV-ET-M60A-2
Product problems
- Material Split, Cut or Torn
Patient
NA · Unknown
- Foreign Body In Patient
- Insufficient Information
Narrative
Description of Event or Problem
I WANTED TO INFORM YOU OF A COMPLAINT REGARDING AN ISSUE THAT HAS ARISEN IN THE FIELD. ONE OF OUR 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.