MAUDE Adverse Event Report: AROA BIOSURGERY OVITEX 1S; SURGICAL MESH

Model Number	F10246-0610P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	12/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on 11dec2025 that a patient was experiencing potential mesh erosion from a hiatal hernia repair.A revision procedure was conducted on (b)(6) 2025.Upon entering abdomen via robotic ports, the original device was found and removed from superior aspect of stomach.It was reported that the permanent suture had eroded into superior aspect of fundoplication.This was "removed easily", stomach irrigated with saline and repaired with resorbable suture.The recurrent hiatal hernia was then repaired with sutures and pledgets.
Additional Manufacturer Narrative
It was noted that the surgeon also utilizes permanent tacks at the hiatus in their hiatal hernia repair procedures and it is unknown whether such usage caused or contributed to the event noted.It could not be confirmed that the device caused or contributed to the event noted.Perforation (i.E.Erosion) and hernia recurrence are potential complications noted in the ovitex instructions for use.

• Brand Name: OVITEX 1S
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): AROA BIOSURGERY; 2 kingsford smith place; airport oaks; auckland 2022 ; NZ 2022
• MDR Report Key: 24008981
• Report Number: 3010513348-2026-00001
• Device Sequence Number: 11964636
• Product Code: FTM
• UDI-Device Identifier: 09421904065086
• UDI-Public: 09421904065086
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/08/2026
• Report Date (Section F): 01/08/2026

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: F10246-0610P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/11/2025
• Event Location: Hospital
• Date Report to Manufacturer: 12/12/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/08/2026