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

Model Number	ESS-G02-SX1
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a150301 is being used to capture the reportable event of anchor exchange failure to release.
Event or Problem Description
It was reported to boston scientific corporation that a overstitch sx endoscopic suture system was attempted to be used during a transoral outlet reduction procedure performed on (b)(6) 2025.Before the procedure a part of the anchor got stuck on the anchor exchange.The procedure outcome is still unknown.There have been no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that a overstitch sx endoscopic suture system was attempted to be used during a transoral outlet reduction procedure performed on (b)(6) 2025.Before the procedure a part of the anchor got stuck on the anchor exchange.The procedure outcome is still unknown.There have been no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.
Additional Manufacturer Narrative
Block h6: device code a150301 is being used to capture the reportable event of anchor exchange failure to release.Block h11: the returned overstitch ess sx was analyzed.A visual inspection was performed, and no damages were found.It was unable to confirm the reported event since the anchor exchange was not returned.Based on all gathered information, the probable cause selected is cause not established, since the analysis of the available information and product analysis of the returned device did not identify any evidence of either the alleged issue(s) or any defect on the device.A product labeling review identified that the device was used per the directions for use (dfu) / product label.

• 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: 21482532
• Report Number: 3005099803-2025-00615
• Device Sequence Number: 12865357
• Product Code: OCW
• UDI-Device Identifier: 20811955020715
• UDI-Public: (01)20811955020715(11)231221(17)261130(10)2023120876
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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,Followup
• Report Date (Section B): 04/17/2025

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: 2023120876
• 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: 02/05/2025
• Supplement Date Received by Manufacturer: 04/06/2025
• Initial Report FDA Received Date: 02/27/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2023
• 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