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

Model Number	SUV-633
Medical Device Problem Codes	Human-Device Interface Problem (2949); 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 an orca was used during an esophagogastroduodenoscopy (egd) and colonoscopy procedures on an unknown date, for screening and surveillance.During the procedure, the a/w and suction buttons are difficult to press.Once pressed, they become stuck and do not return to their normal position.The procedure was completed with another of the same device.There were no patient complication as a result of this event.
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block d2b: subsequent pro-codes: feq, ocx.Block h6: imdrf device code a0509 captures the reportable event of the suction button physical resistance / sticking.Block h11: investigation results.Investigation summary: based on the available information, the root cause of the suction button sticking cannot be established, as the product has not been returned for analysis.Device technical analysis: the device has not been returned for analysis.Therefore, the root cause of the reported suction button sticking cannot be confirmed.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.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: 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: 50155749
• Report Number: 3005099803-2026-03200
• Device Sequence Number: 16110185
• Product Code: ODC
• UDI-Device Identifier: 08714729991144
• UDI-Public: (01)08714729991144(17)290507(10)40470053
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 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-633
• Device Catalogue Number: SUV-633
• Device Lot Number: 0040470053
• 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: 07/08/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 05/08/2026
• 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