MAUDE Adverse Event Report: AROA BIOSURGERY LTD. 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
Additional Manufacturer Narrative
Perforation and hernia recurrence are noted as potential complications in the instructions for use of the device.It cannot be determined whether the device or other patient factors, history, or comorbidities caused or contributed to this event.
Event or Problem Description
It was reported on (b)(6) 2025 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.

• Brand Name: OVITEX 1S
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): AROA BIOSURGERY LTD.; 2 kingsford smith place; airport oaks, auckland 2022 ; NZ 2022
• Manufacturer (Section G): AROA BIOSURGERY LTD.; 2 kingsford smith place; airport oaks, auckland 2022 ; NZ 2022
• Manufacturer Contact: stacey spies ; 2 kingsford smith place; airport oaks, auckland 2022 ; NZ 2022
• MDR Report Key: 24048331
• Report Number: 3007321028-2025-00054
• Device Sequence Number: 9745046
• Product Code: FTM
• UDI-Device Identifier: 09421904065086
• UDI-Public: 09421904065086
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K153632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/13/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown