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

Model Number	SUV-633
Medical Device Problem Codes	Fluid/Blood Leak (1250); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block h6: imdrf device code a050401 captures the reportable event of the a/w valve fluid leak.
Event or Problem Description
It was reported to boston scientific corporation that an orcapod was used during a colonoscopy procedure performed in the colon for screening on (b)(6) 2025.During the procedure, the air/water valve was leaking and could not get full insufflation.The procedure was completed with this device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Additional information: block e1 (initial reporter email).Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block h6: imdrf device code a050401 captures the reportable event of the a/w valve fluid leak.Block h11: correction to block e1 (initial reporter first name).
Event or Problem Description
It was reported to boston scientific corporation that an orcapod was used during a colonoscopy procedure performed in the colon for screening on (b)(6) 2025.During the procedure, the air/water valve was leaking and could not get full insufflation.The procedure was completed with this device.There were no patient complications reported as a result of this event.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22494268
• Report Number: 3005099803-2025-03223
• Device Sequence Number: 8113192
• Product Code: ODC
• UDI-Device Identifier: 08714729991144
• UDI-Public: (01)08714729991144(17)280327(10)36181617
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2025

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
• Operator of Device: Health Professional
• Device Model Number: SUV-633
• Device Catalogue Number: SUV-633
• Device Lot Number: 0036181617
• 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: 06/20/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 09/15/2025
• Date Device Manufactured: 03/28/2025
• 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