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

Model Number	ESS-G02-SX1
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a0501 is being used to capture the reportable event of cap detachment of device or device component.Device evaluation: block h11.The returned overstitch ess sx was analyzed.A visual inspection was performed.The device was returned with the anchor exchange.During the visual inspection, it was found that one of the two traps was detached, which leads to the reported cap detachment.During the media inspection, it can be observed one of the two straps of the end cap is detached and the other one is broken.Therefore, there is enough evidence to confirm the reported events of strap break and cap detachment of device or device component.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.There is no evidence the device was improperly used per the instructions for use (ifu), and there is no evidence that there is any issue with translation, wording, or graphics of the ifu/labeling information.Based on all gathered information, the probable cause selected is adverse event related to procedure, since the adverse event occurred during the procedure and the device had no influence on event.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch ess sx was used during an esg procedure on (b)(6) 2025.During the procedure, after the physician placed 6 sutures, the straps broke.As a result, the endcap detached from the device.The procedure was completed with another device of the same model.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 ess sx was used during an esg procedure on (b)(6) 2025.During the procedure, after the physician placed 6 sutures, the straps broke.As a result, the endcap detached from the device.The procedure was completed with another device of the same model.There was no patient complications reported as a result of this event.
Additional Manufacturer Narrative
H6: device code a0501 is being used to capture the reportable event of cap detachment of device or device component.

• 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: 23185111
• Report Number: 3005099803-2025-04901
• Device Sequence Number: 9815643
• Product Code: OCW
• UDI-Device Identifier: 20811955020715
• UDI-Public: (01)20811955020715(11)241111(17)271031(10)2024110181
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K210266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/27/2026

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: 2024110181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2024
• 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