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

Model Number	ESS-G02-160
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Tissue Injury (4559)
Date of Event	10/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6 device code a040609 is being used to capture the reportable event of needle shaft bent.Imdrf code f2301 is being used to capture the reportable event of additional device required.Imdrf code f1901 is being used to capture the reportable event of additional surgery.Imdrf code e0506 is being used to capture the reportable event of hemorrhage, major.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch endoscopic suture system was used during a fistula repair on october 17, 2025.During the procedure, the needle shaft was bent.Upon removal of the first overstitch device, it was observed there was tissue damage to the esophagus, which caused major bleeding.The bleeding was treated with purastat.An attempt was made to complete the procedure with a second overstitch device, which was also bent.The second overstitch device did not cause any complications.The physician attempted to close the fistula using clips.However, the clips were not successful.The patient had an additional surgery to successfully close the fistula.The patient has made a full recovery.This report is related to the first of two overstitch devices and two overstitch sutures used in the same procedure.Please refer to reports 3005099803-2025-06280 for the first overstitch suture, 3005099803-2025-06117 for the second overstitch device, and 3005099803-2025-06281 for the second overstitch suture.

• 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: 23624027
• Report Number: 3005099803-2025-06116
• Device Sequence Number: 9051703
• Product Code: OCW
• UDI-Device Identifier: 20811955020661
• UDI-Public: (01)20811955020661(11)250328(17)280229(10)2025030080
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K181141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/21/2025

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-G02-160
• Device Catalogue Number: ESS-G02-160
• Device Lot Number: 2025030080
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 11/21/2025
• Date Device Manufactured: 03/28/2025
• 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 Sex: Unknown