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

Model Number	ESS-G02-160
Medical Device Problem Codes	Failure to Align (2522); Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an overstitch ess was utilized during an endoscopic suture sculpt procedure on (b)(6) 2025, for the treatment of obesity and weight loss.During the procedure, the overstitch ess was unable to transfer the needle at exchange for multiple attempts which delayed the case 20 minutes.There appeared to be an alignment issue.The physician used forceps to grab the anchor and remove it from the needle driver.Once the anchor was removed, the physician was able to close the handle and remove the scope from the patient.The procedure was completed with another of the same device.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
Block h6: imdrf code a1702 captures the reportable event of failure to retrieve anchor.Imdrf code f2301 captures the reportable event of additional device required.
Additional Manufacturer Narrative
Block h6: imdrf code a1702 captures the reportable event of failure to retrieve anchor imdrf code f2301 captures the reportable event of additional device required.Investigation results summary the overstitch ess was returned with the anchor exchange for analysis.During the visual inspection it was found the working length catheter was bent.During the microscope inspection, it was observed that the anchor exchange worked successfully to deploy, retrieve and pass the anchor.Additionally, the needle body was not found bent.The overstitch ess worked as expected.During the functional test, the anchor exchange worked successfully to deploy, retrieve and pass the anchor.The reported events of needle shaft failure to align, anchor exchange failure to retrieve anchor and anchor exchange failure to pass anchor could not be confirmed.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.A labeling review was performed using the instructions for use (ifu).Review of the ifu confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.There is no evidence that the device was improperly used per the ifu, and there is no evidence that there is any issue with translation, wording, or graphics of the ifu/labeling information.A risk review of the overstitch ess was completed and confirmed that the events of anchor exchange failure to retrieve anchor, anchor exchange failure to pass anchor, working bent and kinked, prolonged episode of care, additional device required and needle shaft failure to align were defined in the risk documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of device problem excluded.
Event or Problem Description
It was reported that an overstitch ess was utilized during an endoscopic suture sculpt procedure on (b)(6) 2025, for the treatment of obesity and weight loss.During the procedure, the overstitch ess was unable to transfer the needle at exchange for multiple attempts which delayed the case 20 minutes.There appeared to be an alignment issue.The physician used forceps to grab the anchor and remove it from the needle driver.Once the anchor was removed, the physician was able to close the handle and remove the scope from the patient.The procedure was completed with another of the same device.No patient complications were reported as a result of the event.

• Brand Name: OVERSTITCH ENDOSCOPIC SUTURE 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: 23882949
• Report Number: 3005099803-2025-06856
• Device Sequence Number: 21238213
• Product Code: OCW
• UDI-Device Identifier: 20811955020661
• UDI-Public: (01)20811955020661(11)250602(17)280531(10)2025060002
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K181141
• 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,Followup
• Report Date (Section B): 04/07/2026

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-G02-160
• Device Catalogue Number: ESS-G02-160
• Device Lot Number: 2025060002
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2025
• 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: 32 YR
• Patient Sex: Female
• Patient Weight: 104 KG