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 Integrity Problem (2978); 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	10/12/2025
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.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch endoscopic suture system was used during an endoscopic sleeve gastroplasty (esg) procedure on (b)(6) 2025.Prior to the procedure, the handle of the device was damaged.The device was used during the procedure, the physician had difficulty loading the anchor onto the needle body and noted that the needle body was bent.The procedure was completed with a new overstitch 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 endoscopic suture system was used during an endoscopic sleeve gastroplasty (esg) procedure on (b)(6) 2025.Prior to the procedure, the handle of the device was damaged.The device was used during the procedure, the physician had difficulty loading the anchor onto the needle body and noted that the needle body was bent.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 h6: device code a040609 is being used to capture the reportable event of needle shaft bent.Block h11: the returned overstitch endoscopic suture system was analyzed.A visual inspection was performed, and it was observed that the working length was bent, however the needle body was not found bent.It was detected that the handle did not maintain its position when it was actuated from open to close.Considering that there were no evident damages during visual inspection, the handle was disassembled for further analysis, and it was identified that a worn track affected the placement of the follower pin.Based on the information provided by the customer and product analysis, there is not enough evidence to confirm the reported events of device damaged/defective and anchor exchange difficult to pass anchor.Therefore, the most probable cause for this event is selected as "cause not established".For the code needle shaft bent assigned a most probable conclusion code of "no problem detected".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.

• 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: 23525867
• Report Number: 3005099803-2025-05890
• Device Sequence Number: 21087811
• Product Code: OCW
• UDI-Device Identifier: 20811955020661
• UDI-Public: (01)20811955020661(11)250613(17)280531(10)2025060026
• 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): 01/02/2026

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: 2025060026
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2025
• 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: 48 YR
• Patient Sex: Female
• Patient Weight: 78 KG