MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Orca; Endoscope Channel Accessory

Model Number	SUV-629-50
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an orcapod 4 was used during a colonoscopy procedure on (b)(6) 2026.During the procedure, the nurse observed that the water was escaping from the air / watter button.The procedure was completed using this device.There were no patient complications reported as a result of this event and the patient's condition is stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a050401 captures the reportable event of the of air/water valve fluid/blood leak.Block h11: investigation summary: based on the available information, the root cause of the air water valve fluid leak cannot be established, as the product has not been returned for analysis as the product has been disposed.Device technical analysis: the device has not been returned for analysis.Therefore, the root cause of the reported air water valve fluid leak cannot be confirmed.The device history record review confirmed that the device met all material, assembly, and performance specifications prior to distribution.A similar complaint review was completed.There were no emerging trends identified that warrant further action.Investigation conclusion: based on the available information (and in the absence of device return), the root cause of the reported clinical observations cannot be established.

• Brand Name: Orca
• Common Device Name: Endoscope Channel Accessory
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 50291897
• Report Number: 3005099803-2026-03371
• Device Sequence Number: 10727104
• Product Code: ODC
• UDI-Device Identifier: 08714729981589
• UDI-Public: (01)08714729981589(17)290330(10)38973974
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K182275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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: SUV-629-50
• Device Catalogue Number: SUV-629-50
• Device Lot Number: 0038973974
• 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: 07/21/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 08/18/2026
• Supplement Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 03/31/2026
• 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