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

Model Number	ESS-G02-SX1
Medical Device Problem Codes	Difficult to Open or Close (2921); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a051104 is being used to capture the reportable event of needle shaft failure to close.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch sx endoscopic suture system was used in the stomach during a transoral outlet reduction (tore) procedure on (b)(6) 2026.During the procedure, the needle shaft failed too fully close.The patient's tissue was stuck on the handle and manipulation of the handle released the tissue.The procedure was completed with a new overstitch handle.There was no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device code a051104 is being used to capture the reportable event of needle shaft failure to close.Device evaluation: block h11: the returned overstitch ess sx was analyzed.A visual inspection was performed.The device was returned without the anchor exchange.During the visual inspection it can be seen that the working length was detached.It is also possible to identify kinks in the tubing channels and failure to retract and close the handle.The reported event of needle shaft failure to close can be confirmed.A risk review of the overstitch ess sx was completed and confirmed that the events of needle shaft failure to close, catheter detached/separated and catheter bent/kinked were defined in the risk documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.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 most 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.Most likely procedural factors such as handling of the device and the technique used by the physician (force applied), could have resulted in the damages encountered in the device.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch sx endoscopic suture system was used in the stomach during a transoral outlet reduction (tore) procedure on (b)(6) 2026.During the procedure, the needle shaft failed to fully close.The patient's tissue was stuck on the handle and manipulation of the handle released the tissue.The procedure was completed with a new overstitch handle.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: 24458910
• Report Number: 3005099803-2026-00751
• Device Sequence Number: 21333950
• Product Code: OCW
• UDI-Device Identifier: 20811955020715
• UDI-Public: (01)20811955020715(11)241014(17)270930(10)2024100698
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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): 04/02/2026

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: 2024100698
• 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: 01/29/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2024
• 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 Age: 52 YR
• Patient Sex: Female
• Patient Weight: 81 KG