MAUDE Adverse Event Report: Apollo Endosurgery OverStitch NXT Endoscopic Suturing System; Endoscopic Tissue Approximation Device

Model Number	ESS-G02-NXT
Medical Device Problem Codes	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	06/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an overstitch nxt was used in the stomach during an endoscopic sleeve gastroplasty (esg) procedure on (b)(6)2026.During the procedure, after several sutures had been placed, one of the catheters on the overstitch nxt device detached from the device distal end.To remove the device, the placed sutures were cut using ensizor scissors, and the device was removed along with the endoscope.A new overstitch nxt device was prepared and used to successfully complete the procedure as intended.The event prolonged the procedure by approximately 20 minutes.There was no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 is being used to capture the reportable event of catheter detachment.Imdrf impact code f2301 is being used to capture the reportable event of additional device required.

• Brand Name: OverStitch NXT Endoscopic Suturing 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 ; +1(914)571-6918
• MDR Report Key: 50000545
• Report Number: 3005099803-2026-03011
• Device Sequence Number: 10613480
• Product Code: OCW
• UDI-Device Identifier: 10811955020893
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K231553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ESS-G02-NXT
• Device Catalogue Number: ESS-G02-NXT
• Device Lot Number: 2025040013
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2026
• Supplement Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 156 LB