MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIVATOR EMR; ENDOSCOPE AND/OR ACCESSORIES

Model Number	M00561600
Medical Device Problem Codes	Failure to Fire (2610); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: impact code f1001 captures the reportable event of procedure cancelled/rescheduled.
Event or Problem Description
It was reported to boston scientific corporation that a speedband superview super 7 was used in the upper gastrointestinal (gi) tract during an upper endoscopy procedure performed on (b)(6) 2025.During the procedure, the bands were unable to deploy, which resulted in difficult visualization.The procedure was not completed due to the event.There were no patient complications reported as a result of this event.

• Brand Name: CAPTIVATOR EMR
• Common Device Name: ENDOSCOPE AND/OR ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23467231
• Report Number: 3005099803-2025-05721
• Device Sequence Number: 21061686
• Product Code: FDI
• UDI-Device Identifier: 08714729842675
• UDI-Public: (01)08714729842675(17)260502(10)36966943
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K140726
• 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): 07/13/2026

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 Expiration Date: 05/02/2026
• Device Model Number: M00561600
• Device Catalogue Number: M00561600
• Device Lot Number: 0036966943
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 07/13/2026
• Date Device Manufactured: 05/02/2025
• 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