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

Model Number	ESS-G02-NXT
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Integrity Problem (2978); Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
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 unknown procedure on (b)(6) 2025.During the procedure, the anchor exchange became twisted.The needle shaft was bent and would no longer retrieve the anchor.The procedure was delayed for approximately 30 minutes and 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 a040609 is being used to capture the reportable event of needle shaft bent.Device code a1702 is being used to capture the reportable event of anchor exchange failure to retrieve anchor.
Additional Manufacturer Narrative
Block h6: device code a040609 is being used to capture the reportable event of needle shaft bent.Device code a1702 is being used to capture the reportable event of anchor exchange failure to retrieve anchor.Device evaluation: h11: investigation summary: the returned overstitch nxt was analyzed.A visual inspection, microscope inspection, and functional test were performed.The device was returned without the anchor exchange.During the visual inspection it was observed that the needle shaft was bent and two endcap straps were detached.During the microscope inspection, the needle body was found bent.Additionally, during the handle actuation, it was difficult to open and closed.The functional test it is not possible to perform because the anchor exchange was not returned.The reported events of needle shaft bent, and anchor exchange failure to retrieve anchor, could be confirmed.However, it is not possible identify the anchor exchange twisted.For this reason, it is not possible confirm the reported event of "device damaged/defective".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.This investigation is assigned a most probable conclusion code of "adverse event related to procedure".Most likely procedural factors such as handling of the device and the technique used by the physician (force applied), could have resulted in the damages encountered in the device.For this reason, this event is catalogued as "adverse event related to procedure" because the adverse event occurred during the procedure and the device had no influence on event.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.For this reason, will be classified as "cause not established".All compiled information on this investigation determines that the most probable cause is adverse event related to 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.During the procedure, the anchor exchange became twisted.The needle shaft was bent and would no longer retrieve the anchor.The procedure was delayed for approximately 30 minutes and 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: 23531540
• Report Number: 3005099803-2025-05865
• Device Sequence Number: 21103133
• 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: FR
• 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): 03/12/2026

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 54 YR
• Patient Sex: Female
• Patient Weight: 92 KG