MAUDE Adverse Event Report: APOLLO ENDOSURGERY OVERSTITCH SX ENDOSCOPIC SUTURE SYSTEM; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number	ESS-G02-SX1
Medical Device Problem Codes	Failure to Align (2522); Device-Device Incompatibility (2919); Difficult to Open or Close (2921); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6 device code a051104 is being used to capture the reportable event of needle shaft failure to close.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch sx endoscopic suture system was used during an esg procedure on (b)(6) 2025.During the procedure, the needle body was misaligned, and the physician could not transfer the suture.The overstitch was removed from patient in an open position.The procedure was completed with a different device.There was no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch sx endoscopic suture system was used during an esg procedure on (b)(6) 2025.During the procedure, the needle body was misaligned, and the physician could not transfer the suture.The overstitch was removed from patient in an open position.The procedure was completed with a different device.There was no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device code a051104 is being used to capture the reportable event of needle shaft failure to close.Correction: block h6 device code a1702 is being used to capture the event of anchor exchange failure to pass anchor.
Additional Manufacturer Narrative
Block h6: device code a051104 is being used to capture the reportable event of needle shaft failure to close.Correction: block h6 device code a1702 is being used to capture the event of anchor exchange failure to pass anchor.Device evaluation: block h11 the returned overstitch sx endoscopic suture system was analyzed.The device was returned without the anchor exchange.During the visual inspection it was observed that the biopsy valve was detached and broken.During the microscope inspection, the needle body was not found bent.The device was observed in good conditions and that during microscope inspection device worked as expected.However, during the handle actuation it was difficult to retract.It was not possible to perform a functional test because the anchor exchange did not return.Therefore, the reported events of needle shaft failure to align, needle shaft failure to close and anchor exchange failure to pass anchor could not be confirmed.A risk review of the overstitch ess sx was completed and confirmed that the events of needle shaft failure to align, needle shaft failure to close, handle difficult to retract, luer cracked, luer detached/separated and anchor exchange failure to pass 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, the probable cause selected for the events of needle shaft failure to align and needle shaft failure to close is "device problem excluded", since the device was observed in good conditions and worked as expected during the microscope inspection.For the events of difficult to retract and the observation that the biopsy valve was detached and broken, the most probable conclusion code for these events is "adverse event related to procedure".Most likely procedural factors as handling of the device and the technique used by the physician (force applied), could have resulted in the damages encountered in the device because the adverse event occurred during the procedure and the device had no influence on event.There is not enough evidence to determine whether the event of anchor exchange failure to pass anchor was due to the physician's technique during the procedure or was related to a device malfunction.For this reason, "unable to exclude device problem" is selected as the most probable cause for this event.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.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch sx endoscopic suture system was used during an esg procedure on (b)(6) 2025.During the procedure, the needle body was misaligned, and the physician could not transfer the suture.The overstitch was removed from patient in an open position.The procedure was completed with a different device.There was no patient complications reported as a result of this event.

• Brand Name: OVERSTITCH SX ENDOSCOPIC SUTURE 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: 23525827
• Report Number: 3005099803-2025-05897
• Device Sequence Number: 10202826
• Product Code: OCW
• UDI-Device Identifier: 20811955020715
• UDI-Public: (01)20811955020715(11)240614(17)270531(10)2024060490
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: K210266
• 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-SX1
• Device Catalogue Number: ESS-G02-SX1
• Device Lot Number: 2024060490
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 11/27/2025; 02/25/2026
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 12/22/2025; 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2024
• 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 Age: 35 YR
• Patient Sex: Female