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 d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf code f1001 captures the reportable event of absence of treatment.
Event or Problem Description
Note: this record represents the third 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: 25325163
• Report Number: 3005099803-2026-02185
• Device Sequence Number: 18642682
• Product Code: FED
• UDI-Device Identifier: 20811955020708
• UDI-Public: (01)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,Followup
• Report Date (Section B): 07/09/2026

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
• 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
• Supplement Date Received by Manufacturer: 06/14/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 07/09/2026
• 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