MAUDE Adverse Event Report: GUNZE LIMITED NEOVEIL; MESH, SURGICAL, ABSORBABLE, STAPLE LINE REINFORCEMENT, PRODUCT CODE: OXC

Model Number	NV-ET-M60A-2
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	01/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
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.

• Brand Name: NEOVEIL
• Common Device Name: MESH, SURGICAL, ABSORBABLE, STAPLE LINE REINFORCEMENT, PRODUCT CODE: OXC
• Manufacturer (Section D): GUNZE LIMITED; 46 natsumegaichi, aono; ayabe; kyoto, 623-8 513; JA 623-8513
• MDR Report Key: 25344872
• Report Number: 3012602431-2026-00046
• Device Sequence Number: 14774852
• Product Code: OXC
• UDI-Device Identifier: 04547301462534
• UDI-Public: 04547301462534
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/31/2026
• Report Date (Section F): 05/31/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: NV-ET-M60A-2
• Device Catalogue Number: NV-ET-M60A-2
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/17/2026
• Event Location: Hospital
• Date Report to Manufacturer: 05/31/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/31/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GOLD PANTHER STAPLERS CADF-60S
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/31/2026