MAUDE Adverse Event Report: APOLLO ENDOSURGERY OVERSTITCH SX ENDOSCOPIC SUTURE SYSTEM; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number	ESS-G02-SX1
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: device code a0501 is being used to capture the reportable event of detachment of device or device component.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch 2-0 polypropylene suture was used during an esg procedure on (b)(6) 2025.During the procedure, after placing 11 sutures, the anchor would not unload from the needle body.The suture then separated from the needle when the physician tried to cinch.As a result, the suture sequence had to be repeated.The procedure was completed with the original device.There was no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch sx endoscopic suture system was used during an esg procedure on (b)(6) 2025.During the procedure, after placing 11 sutures, the anchor would not unload from the needle body.The suture then separated from the needle when the physician tried to cinch.As a result, the suture sequence had to be repeated.The procedure was completed with the original device.There was no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Correction: block d4: product information updated based on additional information received on december 2, 2025.Block h6: device code a1702 is being used to capture the reportable event of anchor exchange failure to retrieve anchor.

• Brand Name: OVERSTITCH SX ENDOSCOPIC SUTURE SYSTEM
• Common Device Name: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): APOLLO ENDOSURGERY; 1120 s. capital of texas hwy; bldg 1 suite 300; austin TX 78746
• Manufacturer (Section G): VIANT MEDICAL INC; 5079 33rd street; grand rapids MI 49512
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23253593
• Report Number: 3005099803-2025-05124
• Device Sequence Number: 21395159
• Product Code: OCW
• UDI-Device Identifier: 10811955020732
• UDI-Public: (01)10811955020732(11)240429(17)290429(10)24SE4587
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K210266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ESS-G02-SX1
• Device Catalogue Number: ESS-G02-SX1
• Device Lot Number: 2024020002
• 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: 09/15/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 10/09/2025
• Supplement Report FDA Received Date: 12/15/2025
• Date Device Manufactured: 02/01/2024
• 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
• Patient Sex: Female