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); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
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.During the procedure, the needle body became bent and misaligned.As a result, three suture anchors were also bent.The procedure was completed using the original device following an approximate 30-minute procedural delay related to the bending and misalignment.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.
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.During the procedure, the needle body became bent and misaligned.As a result, three suture anchors were also bent.The procedure was completed using the original device following an approximate 30-minute procedural delay related to the bending and misalignment.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 evaluation.Block h11.The returned overstitch endoscopic suture system was analyzed.Additionally, documentation submitted with the complaint includes a picture showing the patient's anatomy during the surgical procedure where the overstitch suture can be identified.A visual inspection and media analysis was performed.The device was returned with the anchor exchange, and the visual inspection did not detect any defects.During the microscope inspection, the needle body was not found bent.The reported events of needle shaft bent and needle shaft failure to align could not 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 is device problem excluded, because the visual and microscope inspections of the device could not confirm the reported events.For the event prolonged episode of care, it happened during the procedure, and the most probable cause of this reported issue cannot be established due to lack of evidence.For this reason, it will be classified as cause not established.

• 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: 23932276
• Report Number: 3005099803-2025-06954
• Device Sequence Number: 18548479
• Product Code: OCW
• UDI-Device Identifier: 20811955020661
• UDI-Public: (01)20811955020661(11)250611(17)280531(10)2025060017
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 02/10/2026

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: 2025060017
• 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: 12/05/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2025
• 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