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

Model Number	ESS-G02-NXT
Medical Device Problem Codes	Defective Device (2588); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946)
Date of Event	12/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf code f1001 captures the reportable event of absence of treatment.Imdrf code e0506 captures the reportable event of hemorrhage.Imdrf code e2009 captures the reportable event of laceration.Imdrf code f2301: captures the reportable event of additional device required.Imdrf code a0501: captures the reportable event of cap detachment.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch nxt endoscopic suturing system was used during a gastric fistula repair procedure performed on (b)(6) 2024.During the procedure, the overstitch nxt is assembled as shown in the training.After making the first stitch in the gastric mucosa, an attempt is made to make a second stitch, but the space is very small and almost prevents the movement and vision of the endoscope.After several attempts to adjust the position (moving the endoscope) to be able to work and especially to have vision, we see the dark part of the endcap on the screen and understand that that part has been welded/loosened.After releasing the needle and closing the system to be able to exit with maximum safety, the needle remains trapped in the system, causing a new complication.Finally, the thread-needle union breaks, and we can leave, verifying that, indeed, the final part has completely come out of the endoscope.The procedure was completed with a fully covered esophageal prosthesis due to subsequent bleeding from a laceration.Patient fully recovered from the event and another surgery has been scheduled.
Additional Manufacturer Narrative
Block h6: imdrf code f1001 captures the reportable event of absence of treatment.Imdrf code e0506 captures the reportable event of hemorrhage.Imdrf code e2009 captures the reportable event of laceration.Imdrf code f2301: captures the reportable event of additional device required.Imdrf code a0501: captures the reportable event of cap detachment.Device evaluation: the overstitch nxt was returned with an anchor exchange for analysis.Based on the information provided in this investigation determines that the most probable cause is cause not established.The reported event of detachment of device or device component was confirmed via customer provided photos in which it was observed the endoscope detached from the endcap.Endcap tape hooks returned with some residues from the procedure.The handle was actuated, and the needle body was able to open and closed without problems.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch nxt endoscopic suturing system was used during a gastric fistula repair procedure performed on (b)(6)2024.During the procedure, the overstitch nxt is assembled as shown in the training.After making the first stitch in the gastric mucosa, an attempt is made to make a second stitch, but the space is very small and almost prevents the movement and vision of the endoscope.After several attempts to adjust the position (moving the endoscope) to be able to work and especially to have vision, we see the dark part of the endcap on the screen and understand that part has been welded/loosened.After releasing the needle and closing the system to be able to exit with maximum safety, the needle remains trapped in the system, causing a new complication.Finally, the thread-needle union breaks, and we can leave, verifying that, indeed, the final part has completely come out of the endoscope.The procedure was completed with a fully covered esophageal prosthesis due to subsequent bleeding from a laceration.Patient fully recovered from the event and another surgery has been scheduled.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21001540
• Report Number: 3005099803-2024-06516
• Device Sequence Number: 13228447
• Product Code: OCW
• UDI-Device Identifier: 10811955020893
• UDI-Public: 10811955020893
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 03/07/2025

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 Lot Number: 2024050684
• 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: 12/03/2024
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 12/23/2024
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2024
• 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 Sex: Unknown