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); 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	09/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an overstitch endoscopic suture system used during a procedure on (b)(6) 2025.During the procedure, the physician was unable to transfer the needle because the needle body was misaligned.The procedure was delayed by 25 minutes and completed with a different 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.Block h11: the returned overstitch device was analyzed.Visual inspection identified a bend along the catheter working length.Microscopic examination showed the needle body to be in good condition with no evidence of deformation or damage.During functional testing, the anchor exchange mechanism operated as intended, successfully deploying and passing the anchor.The reported events of needle shaft bent, anchor exchange failure to retrieve anchor, and anchor exchange failure to pass anchor could not be confirmed during this analysis.The observed bend in the catheter is most consistent with procedural factors, such as device handling and/or physician technique.Since the reported events were not found during analysis, the most probable root cause is "no problem detected.".
Event or Problem Description
It was reported to boston scientific corporation that an overstitch endoscopic suture system used during a procedure on (b)(6) 2025.During the procedure, the physician was unable to transfer the needle because the needle body was misaligned.The procedure was delayed by 25 minutes and completed with a different 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: 23318468
• Report Number: 3005099803-2025-05465
• Device Sequence Number: 14736235
• Product Code: OCW
• UDI-Device Identifier: 20811955020661
• UDI-Public: (01)20811955020661(11)250512(17)280430(10)2025050028
• 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): 12/10/2025

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: 2025050028
• 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: 09/22/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2025
• 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: 25 YR
• Patient Sex: Female
• Patient Weight: 89 KG