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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf code a0501 captures the reportable event of detachment of device or device component.
Event or Problem Description
It was reported to boston scientific that an overstitch ess sx was used in the stomach during an endoscopic sleeve gastroplasty procedure on (b)(6) 2025.During the procedure, the white straps, which hold the end cap of the device onto the endoscope, broke during the last suture line of the esg procedure.The physician could not finish the last line but considered the procedure complete.The physician opted to pass an ensizor through the scope channel to cut the extra suture material.The procedure was completed with the original device.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
Block h6: imdrf code a0501 captures the reportable event of detachment of device or device component.Block h11 device evaluation summary: the overstitch sx was returned for analysis.During the visual inspection it was observed that one catheter channel was kinked, two catheter straps were not returned, and three catheter straps were broken.The reported event of strap break was confirmed.The reported event of cap detachment of device or device component was not confirmed due to a lack of evidence.All compiled information on this investigation determines that the most probable cause is adverse event related to procedure because 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 that an overstitch ess sx was used in the stomach during an endoscopic sleeve gastroplasty (esg) procedure on (b)(6) 2025.During the procedure, the white straps, which hold the end cap of the device onto the endoscope, broke during the last suture line of the esg procedure.The physician could not finish the last line but considered the procedure complete.The physician opted to pass an ensizor through the scope channel to cut the extra suture material the procedure was completed with the original device.No patient complications were reported as a result of the 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22286775
• Report Number: 3005099803-2025-02822
• Device Sequence Number: 18222544
• 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: 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): 09/09/2025

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: 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: 05/23/2025
• Supplement Date Received by Manufacturer: 08/17/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 09/09/2025
• 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 Sex: Unknown