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

Model Number	ESS-G02-SX1
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6.Device code a0501 is being used to capture the reportable event of cap detachment of device or device component.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch sx endoscopic suture system was used during an endoscopic sleeve gastroplasty procedure performed on (b)(6) 2025.During the procedure, the strap at the distal end of the device broke, resulting in the endcap being detached.The procedure was completed with another device from the same model.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch sx endoscopic suture system was used during an endoscopic sleeve gastroplasty procedure performed on (b)(6) 2025.During the procedure, the strap at the distal end of the device broke, resulting in the endcap being detached.The procedure was completed with another device from the same model.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device code a0501 is being used to capture the reportable event of cap detachment of device or device component.Block h11: the returned overstitch ess sx was evaluated.Visual inspection confirmed that one of the two straps on the endcap was detached and not returned with the device, and the remaining strap was fractured.These findings provide sufficient evidence to support the events of cap detachment and strap breakage.Based on the condition of the device, it is most likely that procedural factors, including handling of the device and the technique used by the physician (e.G., force applied during use), contributed to the observed damage.A review of manufacturing records confirmed that the device met all manufacturing specifications prior to distribution, and no manufacturing deviations were identified that could have contributed to the reported event.There was no evidence of improper use of the device relative to the instructions for use (ifu).Additionally, there were no issues identified related to ifu labeling content, including translation, wording, or graphics.Based on the available information, the probable root cause of the event is determined to be adverse event related to procedure.

• Brand Name: OVERSTITCH SX 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: 22628710
• Report Number: 3005099803-2025-03486
• Device Sequence Number: 21064757
• Product Code: OCW
• UDI-Device Identifier: 20811955020715
• UDI-Public: (01)20811955020715(11)240415(17)270331(10)2024040469
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K210266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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-SX1
• Device Catalogue Number: ESS-G02-SX1
• Device Lot Number: 2024040469
• 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: 07/03/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2024
• 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