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
Event or Problem Description
It was reported to boston scientific that an overstitch nxt was used in the stomach for treatment of class ii obesity in an endoscopic sleeve gastroplasty procedure on (b)(6) 2025.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.Another overstitch nxt was utilized during the procedure; however, the procedure was not fully completed.Another procedure was scheduled.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
Block h6: imdrf code a0501 captures the reportable event of cap detachment of device or device component.Imdrf code f1001 captures the reportable event of cancelled/rescheduled - post sedation/sedation unknown.Evaluation summary: the overstitch nxt was not returned for analysis.The customer provided a picture showing the endcap and the straps with evidence of slippage during the procedure.Additionally, it can be observed that the endcap is attached to the gastroscope.The report of strap slippage of device or device component can be confirmed.The reported event of end cap detachment of device or device component cannot be confirmed with the evidence provided.The reported event of cancelled/rescheduled - post sedation/sedation unknown occurred during the procedure and the most probable cause of this reported issue cannot be established due to lack of evidence.With all the available information, boston scientific concludes that the most probable cause is cause not established.
Additional Manufacturer Narrative
Block h6: imdrf code a0501 captures the reportable event of cap detachment of device or device component.Imdrf code f1001 captures the reportable event of cancelled/rescheduled - post sedation/sedation unknown.Additional information: b5: describe event or problem.Correction: g1: manufacturer's contact first name, last name, email and phone number.Evaluation summary: the overstitch nxt was not returned for analysis.The customer provided a picture showing the endcap and the straps with evidence of slippage during the procedure.Additionally, it can be observed that the endcap is attached to the gastroscope.The report of strap slippage of device or device component can be confirmed.The reported event of end cap detachment of device or device component cannot be confirmed with the evidence provided.The reported event of cancelled/rescheduled - post sedation/sedation unknown occurred during the procedure and the most probable cause of this reported issue cannot be established due to lack of evidence.With all the available information, boston scientific concludes that that the most probable cause is cause not established.
Event or Problem Description
It was reported to boston scientific that an overstitch nxt was used in the stomach for treatment of class ii obesity in an endoscopic sleeve gastroplasty procedure on (b)(6) 2025.During the procedure, the overstitch nxt distal straps loosened from the gastroscope and completely detached after the third suture.The adhesive tapes no longer adhered to the gastroscope.Another overstitch nxt was utilized during the procedure; however, the procedure was not fully completed.Another procedure was scheduled.No patient complications were reported as a result of the 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): 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: 22478194
• Report Number: 3005099803-2025-03257
• Device Sequence Number: 8544438
• 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): 10/17/2025

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-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: 06/16/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 10/17/2025
• 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