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	10/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6.Device code a0501 is being used to capture the reportable event of cap detachment.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch sx endoscopic suture system was used during an endoscopic sleeve gastroplasty (esg) procedure on (b)(6) 2025.During the procedure, the distal straps on the device broke resulting in the end cap being detached.The procedure was completed using a new overstitch sx device.There was no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6.Device code a0501 is being used to capture the reportable event of cap detachment.Device evaluation: block h11.The overstitch sx endoscopic suture system was not returned; therefore a visual inspection could not be performed.However, the customer provided a picture in which the device can be observed inside the bag, where it is possible to identify that one of the two straps was detached.Therefore, there is enough evidence to confirm the reported event of cap detachment of device or device component.No breakage was observed in the media content.Therefore, it is not possible to confirm the reported event of strap break.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, there is not enough evidence to determine whether the strap break and cap detachment of the device or device component were due to the physician's technique during the procedure or related to a device malfunction, as there is no objective evidence to confirm whether the device bag was sealed or opened.For this reason, "unable to exclude device problem" is selected as the most probable cause for these events.Without proper evaluation of the device, it remains unknown the most probable causes that contributed to the event.Also, the evidence from the product record review did not identify a potential product quality issue or new patient harm.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch sx endoscopic suture system was used during an endoscopic sleeve gastroplasty (esg) procedure on (b)(6) 2025.During the procedure, the distal straps on the device broke resulting in the end cap being detached.The procedure was completed using a new overstitch sx device.There was no patient complications reported as a result of this event.

• 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: 24039186
• Report Number: 3005099803-2026-00158
• Device Sequence Number: 16072888
• Product Code: OCW
• UDI-Device Identifier: 20811955020715
• UDI-Public: (01)20811955020715(11)241120(17)271031(10)2024110459
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

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: 2024110459
• 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: 12/19/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2024
• 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: Unknown