MAUDE Adverse Event Report: APOLLO ENDOSURGERY OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number	ESS-G02-NXT
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: device code a1702 is being used to capture the reportable event of failure to retrieve anchor.Imdrf code f2301 is being used to capture the reportable event of additional device required.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch nxt endoscopic suturing system was used during an edg procedure on october 1, 2025.During the procedure, the physician prepared to place a second suture.Too much tissue was captured by the device and the anchor exchange failed to unload from the needle body.With the anchor still in the patient's tissue, the physician used scissors to cut the suture and left the anchor in the esophageal wall.The procedure was completed with mantis clips to fixate the stent.There was no patient complications reported as a result of this event.

• Brand Name: OVERSTITCH NXT ENDOSCOPIC SUTURING 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23389928
• Report Number: 3005099803-2025-05398
• Device Sequence Number: 10015592
• Product Code: OCW
• UDI-Device Identifier: 00811955020834
• UDI-Public: (01)00811955020834(11)241128(17)271128(10)AF06408
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K231553
• 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
• Report Date (Section B): 10/27/2025

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-NXT
• Device Catalogue Number: ESS-G02-NXT
• Device Lot Number: 23SE7037
• 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: 10/01/2025
• Initial Report FDA Received Date: 10/27/2025
• 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
• Patient Age: 19 YR
• Patient Sex: Male