MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORCAPOD¿; ENDOSCOPE CHANNEL ACCESSORY

Model Number	SUV-633
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Boston scientific orcapod kit compatible with olympus.(single-use air/water, suction and biopsy valve set with water jet connector).Suction valves were too large to fit in the suction valve.

• Brand Name: ORCAPOD¿
• Common Device Name: ENDOSCOPE CHANNEL ACCESSORY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 22622794
• Report Number: 22622794
• Device Sequence Number: 15560773
• Product Code: ODC
• UDI-Device Identifier: 08714729991144
• UDI-Public: (01)08714729991144
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2025
• Report Date (Section F): 07/09/2025

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
• Device Model Number: SUV-633
• Device Catalogue Number: SUV-633
• Device Lot Number: 35652968
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/09/2025