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

Model Number	ESS-G02-160
Medical Device Problem Codes	Nonstandard Device (1420); Difficult to Advance (2920); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an overstitch ess was used in the stomach during an endoscopic submucosal dissection (esd) procedure on (b)(6) 2026.During the procedure, it was difficult to advance the anchor exchange catheter through the scope.When the physician was finally able to extend the catheter, the anchor had disconnected.The needle body was closed and bent the needle shaft.The device was removed from the patient, and the anchor exchange catheter was stuck in the scope.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 d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: device code a040609 is being used to capture the reportable event of needle shaft bent.
Additional Manufacturer Narrative
Block d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: device code a040609 is being used to capture the reportable event of needle shaft bent.Device evaluation: block h11: the overstitch ess was not returned and no media was available for analysis.Product analysis could not be performed, for this reason and due to the lack of evidence, the reported events of needle shaft bent and anchor exchange difficult to advance could not be confirmed.A risk review of the overstitch ess was completed and confirmed that the event of needle shaft bent and anchor exchange difficult to advance 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.A review of the device history record (dhr) could not be performed because the ship history review could not be completed due to the unavailable documentation.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 needle shaft bent and anchor exchange difficult to advance 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.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch ess was used during an endoscopic submucosal dissection (esd) procedure on (b)(6) 2026.During the procedure, it was difficult to advance the anchor exchange catheter through the scope.When the physician was finally able to extend the catheter, the anchor had disconnected.The needle body was closed and bent the needle shaft.The device was removed from the patient, and the anchor exchange catheter was stuck in the scope.The procedure was completed with a new overstitch device.There was no patient complications reported as a result of this event.

• Brand Name: OVERSTITCH 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: 24493262
• Report Number: 3005099803-2026-00790
• Device Sequence Number: 10638630
• Product Code: OCW
• UDI-Device Identifier: 20811955020661
• UDI-Public: (01)20811955020661(11)250602(17)280531(10)2025060002
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K181141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/01/2026

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-G02-160
• Device Catalogue Number: ESS-G02-160
• Device Lot Number: 2025060002
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: 02/26/2026; 05/05/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 03/26/2026; 06/01/2026
• Date Device Manufactured: 06/02/2025
• 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