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

Model Number	ESS-G02-NXT
Medical Device Problem Codes	Difficult to Open or Close (2921); Mechanical Jam (2983); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2025
Type of Reportable Event	Malfunction
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 performed on (b)(6) 2025.During the procedure the handle stopped working.When trying to actuate the handle, it would not close or open.The procedure was cancelled.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.
Additional Manufacturer Narrative
Block h6.Imdrf impact code f1001 is being used to capture the reportable event of procedure cancel/ rescheduled.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 is being used to capture the reportable event of procedure cancel/ rescheduled.Additional information received on april 10, 2025.Block b5 updated.Block h6 updated.Block h11: the device did not return for analysis however the customer provided some pictures.A media inspection was performed, where it can be observed the endcap hooks detached.The reported event of cancelled/rescheduled - post sedation/sedation cannot be confirmed.Since happened during the procedure and the most probable cause of this reported issue cannot be established due to lack of evidence.A product labeling review identified that the device was used per the directions for use (dfu) / product label.
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 performed on (b)(6) 2025.During the procedure the handle stopped working.When trying to actuate the handle, it would not close or open.The procedure was cancelled.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.Additional information received on april 10, 2025.It was difficult to actuate the handle.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 is being used to capture the reportable event of procedure cancel/ rescheduled.Additional information received on april 10, 2025.Block b5 updated.Block h6 updated.Block h11: the device returned for analysis.Also, the customer provided some pictures.The device was returned with the handle actuated, and after some attempts it was found that the handle was stuck, additionally one of the catheter channels was found bent and the endcap tape hooks were not returned.A media inspection was performed, where it can be observed the endcap hooks detached.Based on all gathered information the reported event of cancelled/rescheduled - post sedation/sedation cannot be confirmed.Since happened during the procedure and the most probable cause of this reported issue cannot be established due to lack of evidence.A product labeling review identified that the device was used per the directions for use (dfu) / product label.
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 performed on (b)(6) 2025.During the procedure the handle stopped working.When trying to actuate the handle, it would not close or open.The procedure was cancelled.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.Additional information received on april 10, 2025: it was difficult to actuate the handle.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21763403
• Report Number: 3005099803-2025-01413
• Device Sequence Number: 8490493
• Product Code: OCW
• UDI-Device Identifier: 10811955020893
• UDI-Public: (01)10811955020893(11)240625(17)270531(10)2024060817
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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,Followup
• Report Date (Section B): 07/08/2025

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-NXT
• Device Catalogue Number: ESS-G02-NXT
• Device Lot Number: 2024060817
• 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: 03/19/2025
• Supplement Date Received by Manufacturer: 04/10/2025; 06/13/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 05/06/2025; 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2024
• 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: Male