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

Model Number	ESS-G02-160
Medical Device Problem Codes	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	10/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an overstitch endoscopic suture system was used during a stent fixation procedure on (b)(6) 2025.During the procedure, the handle was difficult to open and close.When the physician tried to close the handle to complete a suture, the needle body did not fully close and they were unable to unload the needle from the needle body.The device was removed and the procedure 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 failure to retrieve anchor.
Additional Manufacturer Narrative
Block h6.Device code a1702 is being used to capture the reportable event of failure to retrieve anchor.Device evaluation.Block h11 the returned overstitch ess was analyzed.A visual inspection was performed.The device was returned with the anchor exchange.During the visual inspection, it was observed that the bottom of the anchor exchange is damaged.Additionally, it is possible identify that the distal part of working length was bent.A functional inspection was performed, and the anchor exchange could hold the anchor suture.It was not possible to complete the functionality test because the handle did not maintain its position when actuated from open to close.A microscope inspection was performed, and it was detected that the handle did not maintain its position when it was actuated from open to close.The pin track was in good condition; however, it was identified that the distal part of the working length was stretched, associated with the bend.For these reasons, there is enough evidence to confirm handle difficult to actuate.Nonetheless the reported event of anchor exchange failure to retrieve anchor is unable to be confirmed.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 reported event of anchor exchange failure to retrieve anchor is cause not established because it was not possible complete the functionality test and there is not enough evidence to confirm this event.For the reported event handle difficult to actuate, the probable cause selected is adverse event related to procedure, since the adverse event occurred during the procedure and the device had no influence on event.
Event or Problem Description
It was reported that an overstitch endoscopic suture system was used during a stent fixation procedure on (b)(6) 2025.During the procedure, the handle was difficult to open and close.When the physician tried to close the handle to complete a suture, the needle body did not fully close and they were unable to unload the needle from the needle body.The device was removed and the procedure 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: 23442248
• Report Number: 3005099803-2025-05731
• Device Sequence Number: 18310808
• Product Code: OCW
• UDI-Device Identifier: 20811955020661
• UDI-Public: (01)20811955020661(11)250310(17)280229(10)2025030022
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 01/27/2026

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: 2025030022
• 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: 10/08/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2025
• 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