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

Model Number	ESS-G02-SX1
Medical Device Problem Codes	Entrapment of Device (1212); Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf code a150208 captures the reportable event of stuck in tissue.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch sx endoscopic suture system was used during an endoscopic sleeve gastroplasty (esg) procedure performed on (b)(6) 2024.During the procedure, the needle driver arm malfunctioned.It had a needle attached to it, but after taking a bit of tissue, the part where the needle driver arm attaches to the needle was bent, not allowing him to remove the needle.The physician attempted to remove the device with graspers, however, was unable due to the angle required.Manually torquing and opening of the handle freed the tissue from the needle/needle driver with only minor bleeding which did not cause concern.The scope and device were then removed from the patient.Procedure was completed with another overstitch sx device.There were no patient complications reported as a result of this event.

• Brand Name: OVERSTITCH SX 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20024063
• Report Number: 3005099803-2024-04030
• Device Sequence Number: 21019815
• Product Code: OCW
• UDI-Device Identifier: 20811955020715
• UDI-Public: 20811955020715
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K210266
• 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
• Report Date (Section B): 08/21/2024

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-SX1
• Device Lot Number: 2024020002
• 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: 07/31/2024
• Initial Report FDA Received Date: 08/22/2024
• Date Device Manufactured: 02/01/2024
• 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
• Patient Sex: Unknown