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

Model Number	ESS-G02-NXT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	11/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an overstitch nxt endoscopic suturing system was used during an endoscopic sleeve gastroplasty (esg) procedure on (b)(6) 2025.The procedure was completed.During withdrawal, a 4cm esophageal laceration was observed.The laceration was repaired using an x-tack device.The patient was hospitalized for 4 days following the procedure.
Additional Manufacturer Narrative
Block h6.Imdrf code e2009 is being used to capture the reportable event of laceration(s).Imdrf code f2301 is being used to capture the reportable event of additional device required.Imdrf code f08 is being used to capture the reportable event of hospitalization or prolonged hospitalization.
Additional Manufacturer Narrative
Block h6: imdrf code e2009 is being used to capture the reportable event of laceration(s).Imdrf code f2301 is being used to capture the reportable event of additional device required.Imdrf code f08 is being used to capture the reportable event of hospitalization or prolonged hospitalization.Correction: block b5: event description has been updated to include the patient's condition following the procedure.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch nxt endoscopic suturing system was used during an endoscopic sleeve gastroplasty (esg) procedure on (b)(6) 2025.The procedure was completed.During withdrawal, a 4cm esophageal laceration was observed.The laceration was repaired using an x-tack device.The patient was hospitalized for 4 days following the procedure.There were no further complications, and the patient was discharged on (b)(6) 2025.Post-procedure, the patient developed hoarseness and required vocal cord rehabilitation.No additional symptoms have been observed at this time.

• 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 ; 9145716918
• MDR Report Key: 23743779
• Report Number: 3005099803-2025-06632
• Device Sequence Number: 10208859
• Product Code: OCW
• UDI-Device Identifier: 10811955020893
• UDI-Public: (01)10811955020893(11)250310(17)280229(10)2025030023
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K231553
• 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): 02/26/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: ESS-G02-NXT
• Device Catalogue Number: ESS-G02-NXT
• Device Lot Number: 2025030023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 02/26/2026
• Date Device Manufactured: 03/10/2025
• 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 Sex: Female