MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Orca; Endoscope Channel Accessory

Model Number	SUV-629-50
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an orcapod 4 was used during procedure performed on an unknown procedure date.During the procedure, the nurse reported that the air/water button leaked continuously throughout the case; requiring her to place a towel beneath the physician to absorb the excess water.The procedure was completed with this device.There were no patient complications reported as a result of this event and the patient's condition is stable.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
B3: date of event: date of event was approximated to 08/01/2026 as no event date was reported.Block d4, h4: the complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.Block h6 (device codes): imdrf device code a050401 captures the reportable event of the of air/water valve fluid/blood leak.

• Brand Name: Orca
• Common Device Name: Endoscope Channel Accessory
• 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, 01752 ; EI 01752
• MDR Report Key: 50534788
• Report Number: 3005099803-2026-03550
• Device Sequence Number: 6040184
• Product Code: ODC
• UDI-Device Identifier: 08714729981589
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K182275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/31/2026

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-629-50
• Device Catalogue Number: SUV-629-50
• 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: 08/04/2026
• Initial Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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