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

Model Number	OVT-027-160
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf code f1001 captures the reportable event of absence of treatment.Block h11: investigation results summary.The overtube was not returned as it was disposed.A product analysis could not be performed.Therefore, the reported events could not be confirmed due to the lack of evidence.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.Based on the event description and information provided by the customer there is not enough evidence to determine whether the cuff damaged/defective was due to the physician's technique during the procedure or was related to a device malfunction.The reported event of cancelled / rescheduled post sedation / sedation unknown occurred during the procedure, and the most probable cause of this reported issue cannot be established due to lack of evidence.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.
Event or Problem Description
Note: this record represents the first of three overtube devices.It was reported to boston scientific that an overtube was used in an endoscopic sleeve gastroplasty (esg) procedure on (b)(6) 2026, for the treatment of obesity.During the procedure, the inflation cuffs on three overtube devices would not inflate.The procedure was cancelled due to patient's distorted anatomy.No patient consequences were reported as a result of the event.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 25325161
• Report Number: 3005099803-2026-02184
• Device Sequence Number: 9920498
• Product Code: FED
• UDI-Device Identifier: 20811955020708
• UDI-Public: (01)20811955020708(11)250609(17)270509(10)2503-2056
• 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): 05/28/2026

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: OVT-027-160
• Device Catalogue Number: OVT-027-160
• Device Lot Number: 2503-2056
• 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: 05/04/2026
• Initial Report FDA Received Date: 05/28/2026
• Date Device Manufactured: 06/09/2025
• 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
• Patient Sex: Unknown