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

Model Number	ESS-G02-NXT
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6 device code a1702 is being used to capture the reportable event of anchor exchange failure to retrieve.
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) 2026.During the procedure, a portion of the anchor exchange release handle came apart from the catheter.As a result, the anchor failed to load and unload from the needle shaft.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 a1702 is being used to capture the reportable event of anchor exchange failure to retrieve.Device evaluation.Block h11: the returned overstitch nxt device and submitted media were analyzed.A visual inspection and media review were performed.The anchor exchange was returned without the overstitch handle.The attached documentation includes an image showing that the white component of the anchor exchange was detached from the blue button.No damage was observed during visual inspection.Functional testing could not be performed because the overstitch handle was not returned.Therefore, the reported events of handle break, anchor exchange failure to pass anchor, and anchor exchange failure to retrieve anchor could not be confirmed.A risk review of the overstitch nxt was completed and confirmed that the events of handle break, anchor exchange failure to pass anchor and anchor exchange failure to retrieve anchor were defined in the risk documentation.These event types have 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 handle break, anchor exchange failure to pass anchor, and anchor exchange failure to retrieve anchor were due to the physician's technique during the procedure or related to a device malfunction.Additionally, the overstitch device was not returned and is required to perform the product analysis to further investigate the reported issues.For this reason, "unable to exclude device problem" is selected as the most probable cause for these events.
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) 2026.During the procedure, a portion of the anchor exchange release handle came apart from the catheter.As a result, the anchor failed to load and unload from the needle shaft.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: 24458925
• Report Number: 3005099803-2026-00752
• Device Sequence Number: 10007794
• Product Code: OCW
• UDI-Device Identifier: 10811955020893
• UDI-Public: (01)10811955020893(11)250421(17)280331(10)2025040055
• 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): 03/18/2026

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: 2025040055
• 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: 01/29/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2025
• 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 Sex: Female
• Patient Weight: 88 KG