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

Model Number	SUV-629-50
Medical Device Problem Codes	Nonstandard Device (1420); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an orcapod 4 was used in the colon during various endoscopy procedures performed on (b)(6) 2026.During the procedure, the physician reported that the suction button stuck in the depressed position.It was also reported that the button detached and popped off the scope.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
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 a0509 captures the reportable event of the suction button physical resistance/sticking.

• 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, MA 01752 ; +1(914)571-6918
• MDR Report Key: 50757275
• Report Number: 3005099803-2026-03757
• Device Sequence Number: 15786157
• Product Code: ODC
• UDI-Device Identifier: 08714729981589
• UDI-Public: (01)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): 09/14/2026

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: 08/22/2026
• Initial Report FDA Received Date: 09/14/2026
• 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