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

Model Number	ESS-G02-160
Medical Device Problem Codes	Failure to Align (2522); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a1702 is being used to capture the reportable event of anchor exchange failure to retrieve.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch endoscopic suture system was used during an endoscopic sleeve gastroplasty (esg) procedure on (b)(6) 2026.Prior to the procedure, the anchor failed to load and unload from the needle shaft.The device was also misaligned.The procedure was completed with a new overstitch device.There was no patient complications reported as a result of this event.This is the second of two overstitch ess devices used in the same procedure.
Additional Manufacturer Narrative
Block h6 device code a1702 is being used to capture the reportable event of anchor exchange failure to retrieve.Device evaluation block h11 the overstitch ess was returned for analysis, and media was submitted with the complaint.The device was returned with the anchor exchange.During the visual inspection, it was not possible identify any damages.The documentation attached included some pictures and videos where it can be observed the physician using the overstitch.However, it is not possible identify any issue.During the microscope inspection, the anchor exchange worked successfully to deploy, retrieve, and pass anchor.Additionally, the needle body was not found bent.The device was observed in good conditions and the device worked as expected during the microscope inspection.During the functional test, the anchor exchange worked successfully to deploy, retrieve, and pass anchor.The reported events of anchor exchange failure to pass anchor, anchor exchange failure to retrieve anchor and needle shaft failure to align could not be confirmed.A risk review of the overstitch ess was completed and confirmed that the events of anchor exchange failure to pass anchor, anchor exchange failure to retrieve anchor and needle shaft failure to align 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 probable cause selected is "device problem excluded", because the device was observed in good conditions and worked as expected during the microscope and functional inspections.The analysis of the available information and product analysis of the returned device did not identify any evidence of either the alleged issues.For the reported events, it happened during the procedure and there is not an objective evidence or descriptive conditions to confirm it.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch endoscopic suture system was used during an endoscopic sleeve gastroplasty (esg) procedure on (b)(6) 2026.Prior to the procedure, the anchor failed to load and unload from the needle shaft.The device was also misaligned.The procedure was completed with a new overstitch device.There was no patient complications reported as a result of this event.This is the second of two overstitch ess devices used in the same procedure.

• Brand Name: OVERSTITCH 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: 24272970
• Report Number: 3005099803-2026-00481
• Device Sequence Number: 15939587
• Product Code: OCW
• UDI-Device Identifier: 20811955020661
• UDI-Public: (01)20811955020661(11)250623(17)280531(10)2025060048
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K181141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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-G02-160
• Device Catalogue Number: ESS-G02-160
• Device Lot Number: 2025060048
• 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: 01/13/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2025
• 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