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

Model Number	SUV-628-50
Medical Device Problem Codes	Fluid/Blood Leak (1250); Suction Problem (2170); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that orcapod 3 was used in the colon during a colonoscopy procedure performed on an unknown procedure date.During the procedure, the red suction button exhibited leakage, sticking when depressed, and intermittent suction problem.When suction stopped functioning, the physician would remove the suction button and occlude the suction port with a finger to restore suction.Although this temporarily resolved the issue, the problem repeatedly recurred throughout the procedure.The procedure was completed with this device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
B3: date of event: date of event was approximated to (b)(6) 2026 as no event date was reported.Block d4, h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Block h6: imdrf device code a0509 captures the reportable event of suction button sticking.Block h11: investigation summary: based on the available information, the root cause of the suction button sticking, leaking, and suction issue cannot be established, as the product has not been returned for analysis.For this reason and due to the lack of evidence is unable to confirm the reported events.The device was not returned for analysis; therefore, a technical analysis could not be performed.A review of the manufacturing documentation for this device was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lot numbers and a manufacturing review of the most probable lot numbers did not identify any anomalies or deviations that could have contributed to the event.A similar complaint review was completed.There were no emerging trends identified that warrant further action.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: 50243509
• Report Number: 3005099803-2026-03313
• Device Sequence Number: 21399361
• Product Code: ODC
• UDI-Device Identifier: 08714729981565
• UDI-Public: (01)08714729981565
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K182275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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-628-50
• Device Catalogue Number: SUV-628-50
• 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: 07/20/2026
• Supplement Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 08/13/2026
• Supplement Report FDA Received Date: 10/02/2026
• 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