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

Model Number	ESS-G02-160
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an overstitch endoscopic suture system was used during an endoscopic sleeve gastroplasty, procedure performed on (b)(6) 2025.During the procedure, the needle bent, preventing the transfer of the suture from the needle driver to the anchor exchange.The procedure was completed with a different device from the same model.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 device code a1702 is being used to capture the reportable event of anchor exchange failure to retrieve anchor.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch endoscopic suture system was used during an endoscopic sleeve gastroplasty, procedure performed on (b)(6) 2025.During the procedure, the needle bent, preventing the transfer of the suture from the needle driver to the anchor exchange.The procedure was completed with a different device from the same model.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device code a1702 is being used to capture the reportable event of anchor exchange failure to retrieve anchor.Block h11: the returned overstitch device was analyzed.A visual and microscope inspection was performed.The device was returned with the catheter working length kinked.The needle body was observed bent conditions, so this could affect directly the anchor exchange and failure to retrieve anchor.Additionally, during microscope inspection, the needle body did not work as expected.Based on the findings, the reported event of anchor exchange failure to retrieve anchor was confirmed.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.A product labeling review identified that the device was used per the directions for use (dfu) / product label.

• 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: 22850339
• Report Number: 3005099803-2025-04216
• Device Sequence Number: 19938158
• Product Code: OCW
• UDI-Device Identifier: 20811955020661
• UDI-Public: (01)20811955020661(11)250121(17)271231(10)2025010058
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/12/2025

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-G02-160
• Device Catalogue Number: ESS-G02-160
• Device Lot Number: 2025010058
• 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: 08/08/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2025
• 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 Age: 35 YR
• Patient Sex: Female
• Patient Weight: 45 KG