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

Model Number	ESS-G02-NXT
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code: a040609 is being used to capture the reportable event of needle shaft bent.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch nxt endoscopic suturing system was used during a procedure on (b)(6) 2025.Prior to the procedure, it was observed that the needle shaft was bent.The procedure was completed with a new overstitch device.There was no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 device code a040609 is being used to capture the reportable event of needle shaft bent.Device evaluation block h11 the overstitch nxt was returned with the anchor exchange.A visual and microscope inspection was performed and found the needle shaft bent.Media analysis was also performed.The documentation attached includes some pictures where it can be observed the device into the pouch with the device label information with the upn and batch number.Additionally, it can be seen the needle shaft bent.There is enough evidence to confirm the reported event of needle shaft bent.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.There is no evidence the device was improperly used per the instructions for use (ifu), and there is no evidence that there is any issue with translation, wording, or graphics of the ifu/labeling information.Based on all gathered information, the probable cause selected is adverse event related to procedure, since the adverse event occurred during the procedure and the device had no influence on event.Most likely procedural factors as handling of the device and the technique used by the physician (force applied), could have resulted in the damages encountered in the device.The evidence from the product record review did not identify a potential product quality issue or new patient harm.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch nxt endoscopic suturing system was used during a procedure on (b)(6) 2025.Prior to the procedure, it was observed that the needle shaft was bent.The procedure was completed with a new overstitch device.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): 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: 23722557
• Report Number: 3005099803-2025-06477
• Device Sequence Number: 10350215
• Product Code: OCW
• UDI-Device Identifier: 10811955020893
• UDI-Public: (01)10811955020893(11)250310(17)280229(10)2025030023
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 03/12/2026

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: 2025030023
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2025
• 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: Female