MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OrcaPod?; pump, air, non-manual, for endoscope

Model Number	SUV-633
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific that orcapod 4 was used during a colonoscopy procedure performed for screening on (b)(6)2026.During the procedure, when the physician pressed the air/water button, water leaked from the device and splashed into the physician's eye.There were no patient complications reported as a result of this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Block d2b: subsequent product codes feq and ocx block h6: imdrf device code a050401 captures the reportable event of the of air/water valve fluid/blood leak.
Event or Problem Description
It was reported to boston scientific that orcapod 4 was used in the colon during a colonoscopy procedure performed for the treatment of screening on (b)(6) 2026.During the procedure, when the physician pressed the air/water button, water leaked from the device and splashed into the physician's eye.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block d2b: subsequent product codes feq and ocx.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 button leaking cannot be established, as the product has not been returned for analysis because it was disposed.Product analysis could not be performed, for this reason and due to the lack of evidence is unable to confirm the reported event.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.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: OrcaPod?
• Common Device Name: pump, air, non-manual, for endoscope
• 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: 50071780
• Report Number: 3005099803-2026-03082
• Device Sequence Number: 10404790
• Product Code: ODC
• UDI-Device Identifier: 08714729991144
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

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-633
• Device Catalogue Number: SUV-633
• Device Lot Number: 0038086540
• 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: 07/02/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 07/29/2026
• Supplement Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 12/02/2025
• 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