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

Model Number	ESS-G02-NXT
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
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 in the stomach on (b)(6) 2026.During the procedure, the endcap detached.There was an attempt to reattach the endcap, but it detached a second time.The procedure was completed with a new overstitch device.There was no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 device code a0501 is being used to capture the reportable event of detachment of device or device component.
Additional Manufacturer Narrative
Block h6 device code a0501 is being used to capture the reportable event of detachment of device or device component.Device evaluation.Block h11 the overstitch nxt was not returned.However, media analysis was performed.The documentation attached includes a picture where it can be observed the device after use with the cap detached.For this reason, there is enough evidence to confirm the reported event of cap detachment of device or device component.A risk review of the overstitch nxt was completed and confirmed that the event of cap detachment of device or device component was defined in the risk documentation.This event type has 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, there is not enough evidence to determine whether the cap detachment of device or device component was due to the physician's technique during the procedure or was related to a device malfunction.For the event prolonged episode of care, it happened during the procedure, and the most probable cause of this reported issue cannot be established due to lack of evidence.Without proper evaluation of the device, it remains unknown the most probable causes that contributed to the event.Also, the evidence from the product record review did not identify a potential product quality issue or new patient harm.All compiled information on this investigation determines that the most probable cause is "unable to exclude device problem".
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 in the stomach on (b)(6) 2026.During the procedure, the endcap detached.There was an attempt to reattach the endcap, but it detached a second time.This event delayed the procedure by approximately 30 minutes.The procedure was completed with a new overstitch device.There was no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 device code a0501 is being used to capture the reportable event of detachment of device or device component.Block b5 additional information received (b)(6) 2026 included the amount of time the procedure was delayed.Block e1 additional information received (b)(6) 2026 reported the physician's phone number and email.
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 in the stomach on (b)(6) 2026.During the procedure, the endcap detached.There was an attempt to reattach the endcap, but it detached a second time.This event delayed the procedure by approximately 30 minutes.The procedure was completed with a new overstitch device.There was no patient complications reported as a result of this event.

• 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: 24302699
• Report Number: 3005099803-2026-00529
• Device Sequence Number: 9678919
• Product Code: OCW
• UDI-Device Identifier: 10811955020893
• UDI-Public: (01)10811955020893(11)250212(17)280131(10)2025020048
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 03/24/2026

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-NXT
• Device Catalogue Number: ESS-G02-NXT
• Device Lot Number: 2025020048
• 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: 01/14/2026
• Supplement Date Received by Manufacturer: 02/03/2026; 02/26/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 02/26/2026; 03/24/2026
• Date Device Manufactured: 02/12/2025
• 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