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

Model Number	ESS-G02-SX1
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Date of Event	04/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: impact code f8 is being used to capture the reportable event of hospitalization.Impact codef1001 is being used to capture the reportable event of absence of treatment.Impact code f23 is being used to capture the reportable event of unexpected medical treatment.Device code a051104 is being used to capture the reportable event of needle shaft failed to close.
Event or Problem Description
It was reported to boston scientific that two overstitch ess sx were used in an endoscopic sleeve gastroplasty procedure on (b)(6) 2025.During the procedure, the first system thread did not click into place at the needle curve of the system as it normally does, so the thread could not be used in the patient, and the procedure was aborted.With the second system, the physician could no longer pass through the patient's esophagus.The patient went to the hospital the same day with severe throat pain and had to stay there for 11 days due to inflammation of the esophagus.This record represents the first overstitch ess sx device.

• 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): APOLLO ENDOSURGERY COSTA RICA S.R.L; alajuela, 02 ; CS
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22011458
• Report Number: 3005099803-2025-02125
• Device Sequence Number: 20806551
• Product Code: OCW
• UDI-Device Identifier: 20811955020715
• UDI-Public: (01)20811955020715
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 05/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 04/17/2025
• Initial Report FDA Received Date: 05/13/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female