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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific that an overstitch sx was used in the esophahoyeyunal anastomosis for the treatment of defects during an endoscopy and defect closure procedure on (b)(6) 2025.During the procedure, the overstitch sx was mounted on the endoscope and the procedure was started.After performing some stitches, it was evident that the overstitch sx comes out of the endoscope.The physician removes the endoscope and finds the distal strap broken.The procedure was completed with another overstitch sx.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
Block h6: imdrf code a0501 captures the reportable event of detachment of device or device component.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22370315
• Report Number: 3005099803-2025-03024
• Device Sequence Number: 4389332
• Product Code: OCW
• UDI-Device Identifier: 20811955020715
• UDI-Public: (01)20811955020715(11)240904(17)270831(10)2024090010
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/01/2025

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: 2024090010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 07/01/2025
• Date Device Manufactured: 09/04/2024
• 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: Male
• Patient Weight: 55 KG