MAUDE Adverse Event Report: APOLLO ENDOSURGERY OVERTUBE ENDOSCOPIC ACCESS SYSTEM; ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY

Model Number	OVT-027-160
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturing report number 3005099803-2024-01049 for the overstitch nxt endoscopic suturing system and 3005099803-2024-01220 for the overtube endoscopic access system.It was reported to boston scientific corporation that an overstitch nxt endoscopic suturing system was used in a transoral outlet reduction (tore) performed on (b)(6) 2024.During the procedure, there was some resistance when maneuvering the overstitch through the overtube and it was noted that the overtube was torn.It was reported that there was less inflation than they wanted.In the physician's assessment the resistance and maneuvering may have caused the tear.The procedure was successfully completed with these devices.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Imdrf device code a1702 captures the reportable event of difficulty advancing the overstitch through the overtube.

• Brand Name: OVERTUBE ENDOSCOPIC ACCESS SYSTEM
• Common Device Name: ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): APOLLO ENDOSURGERY; 1120 s. capital of texas hwy; bldg 1 suite 300; austin TX 78746
• Manufacturer (Section G): ROSE TECHNOLOGIES COMPANY; 1440 front avenue nw; grand rapids MI 49504
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18959055
• Report Number: 3005099803-2024-01220
• Device Sequence Number: 9445672
• Product Code: FED
• UDI-Device Identifier: 20811955020708
• UDI-Public: 20811955020708
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K122270
• 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): 03/22/2024

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 Expiration Date: 10/14/2025
• Device Model Number: OVT-027-160
• Device Lot Number: 2306-2049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2023
• 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