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

Model Number	ESS-G02-160
Medical Device Problem Codes	Failure to Align (2522); Device-Device Incompatibility (2919); 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	11/14/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch endoscopic suture system was used during a procedure on (b)(6) 2025.During the procedure, the physician was unable to transfer the needle.With each bite attempt, the curved needle failed to align with the suture anchor and was bent.The procedure was delayed by approximately 25 minutes.A new overstitch was used to complete the procedure.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 endoscopic suture system was used during a procedure on (b)(6) 2025.During the procedure, the physician was unable to transfer the needle.With each bite attempt, the curved needle failed to align with the suture anchor and was bent.The procedure was delayed by approximately 25 minutes.A new overstitch was used to complete the procedure.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.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 found the working length bent.The device was observed in good conditions and during microscope inspection and functionality test, the device worked as expected.The anchor exchange worked successfully to deploy, retrieve, and pass anchor.Additionally, the needle body was not found bent.Therefore, the reported events of "anchor exchange failure to pass anchor, anchor exchange failure to retrieve anchor, needle shaft bent and needle shaft failure to align" could not be confirmed.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 events is "device problem excluded", because the anchor exchange worked successfully to deploy, retrieve, and pass the anchor, and the needle body was not found bent.For the issue detected during the visual inspection of "working length bent" a most probable conclusion code of "adverse event related to procedure" was assigned because the adverse event occurred during the procedure and the device had no influence on 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: 23801057
• Report Number: 3005099803-2025-06710
• Device Sequence Number: 18489188
• Product Code: OCW
• UDI-Device Identifier: 20811955020661
• UDI-Public: (01)20811955020661(11)250506(17)280430(10)2025050017
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 03/05/2026

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: 2025050017
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2025
• 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: Male
• Patient Weight: 100 KG