MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORCAPOD?; PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE

Model Number	SUV-633
Medical Device Problem Codes	Difficult to Remove (1528); Human-Device Interface Problem (2949); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific that orca suction button was used in a procedure performed on an unknown procedure date.During the procedure, the physician had difficulty pressing the suction button.When the staff attempted to remove the button, they also encountered difficulty detaching it from the scope.The procedure was completed with another of the same device.There were no patient complications as a result of this event.This event has been deemed a reportable event based on the investigation results; suction button sticking.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block b3: date of event: date of event was approximated to 01/01/2026 as no event date was reported.Block d2b: subsequent product codes feq and ocx.Block h6: imdrf device code a0509 is being used to capture the investigation results of suction button sticking.Block h11: one suction valve was returned for analysis.Visual inspection of the returned device showed damage to the chamfer of the shaft in the form of a burr.Returned suction valve shaft failed functional tests with a sample scope; the valve was able to be inserted into the scope port with difficulty and was stuck when the button was pressed.Product analysis results indicate that the shaft diameter of the suction valve shaft was within specification; however, damage to the shaft chamfer was noted in the form of a burr.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.The reported complaint was confirmed.Product analysis of the returned suction valve noted physical damage in the form of a burr to the shaft chamfer.An investigation to address this problem is in progress.Based on all gathered information, the probable cause of the reported event is manufacturing deficiency, indicating that the reported device problem can be traced to the manufacturing process, specifically of the supplier as the shaft is a supplier provided part.

• 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 ; 9145716918
• MDR Report Key: 25330747
• Report Number: 3005099803-2026-02191
• Device Sequence Number: 21283514
• Product Code: ODC
• UDI-Device Identifier: 08714729991144
• UDI-Public: (01)08714729991144(17)280820(10)37267329
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K182275
• 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
• Report Date (Section B): 05/29/2026

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: 0037267329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2025
• 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