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

Model Number	ESS-G02-NXT
Medical Device Problem Codes	Device Slipped (1584); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf code a0501 captures the reportable event of cap detachment of device or device component.
Event or Problem Description
It was reported to boston scientific that an overstitch nxt for the treatment of class ii obestity during an endoscopic sleeve gastroplasty procedure on an unknown date.During the procedure, the overstitch nxt loosened from the gastroscope and completely detached after the third suture.The adhesive tapes no longer adhered to the gastroscope.The endcap detached from the overstitch device.The procedure was completed with another overstitch nxt.No patient complications were reported as a result of the event.
Event or Problem Description
It was reported to boston scientific that an obesity nxt during an endoscopic sleeve gastroplasty procedure for the treatment of class ii obestity on an unknown date.During the procedure, the overstitch nxt loosened from the gastroscope and completely detached after the third suture.The adhesive tapes no longer adhered to the gastroscope.The endcap detached from the overstitch device.The procedure was completed with another overstitch nxt.No patient complications were reported as a result of the event.Based on additional information received on october 9, 2025: the straps that slipped and detached were those located at the distal end of the device.
Additional Manufacturer Narrative
Block h6: imdrf code a0501 captures the reportable event of cap detachment of device or device component.Additional information: block b5: updated based on additional information received on october 9, 2025.Correction: g1: manufacturer's contact first name, last name, email and phone number.

• 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): 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: 22902019
• Report Number: 3005099803-2025-04250
• Device Sequence Number: 7910997
• Product Code: OCW
• UDI-Device Identifier: 10811955020893
• UDI-Public: (01)10811955020893(11)250114(17)271231(10)2025010032
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2025

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-NXT
• Device Catalogue Number: ESS-G02-NXT
• Device Lot Number: 2025010032
• 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: 08/01/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 10/20/2025
• Date Device Manufactured: 01/14/2025
• 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
• Patient Sex: Unknown