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

Model Number	SUV-629-50(01)08714729981589
Medical Device Problem Codes	Break (1069); Suction Problem (2170); Infusion or Flow Problem (2964); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4 and h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a0509 captures the reportable event of suction button sticking.
Event or Problem Description
It was reported to boston scientific corporation that orca valve was used during colonoscopy and esophagogastroduodenoscopy (egd) procedures performed on (b)(6) 2026.During the procedure, they reported frequent issues with the new buttons, including weak and no insufflation, inadequate suction, the suction button becoming stuck in the depressed position, and one instance in which the button stem broke off into the scope valve during bedside cleaning.The procedure was completed using an alternative device.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that orca valve was used during colonoscopy and esophagogastroduodenoscopy (egd) procedures performed on (b)(6) 2026.During the procedure, they reported frequent issues with the new buttons, including weak and no insufflation, inadequate suction, the suction button becoming stuck in the depressed position, and one instance in which the button stem broke off into the scope valve during bedside cleaning.The procedure was completed using an alternative device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4 and h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a0509 captures the reportable event of suction button sticking.Block h11: investigation results.Based on the available information, the root cause of the suction button sticking cannot be established, as the product has not been returned for analysis as it was disposed.The device has not been returned for analysis.Therefore, the root cause of the reported suction button sticking cannot be confirmed.A similar complaint review was completed.There were no emerging trends identified that warrant further action.Based on the event description and information provided by the customer there is not enough evidence to determine whether the a/w valve flow issue, suction button sticking, suction valve break and suction valve suction issue was due to the physicians technique during the procedure or was related to a device malfunction.Based on the available information and in the absence of device return the root cause of the reported clinical observations cannot be established.

• 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, ; EI
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 25788503
• Report Number: 3005099803-2026-02761
• Device Sequence Number: 12184202
• Product Code: ODC
• UDI-Device Identifier: 08714729981589
• UDI-Public: (01)08714729981589
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K182275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2026

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(01)08714729981589
• Device Catalogue Number: SUV-629-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2026
• Supplement Date Received by Manufacturer: 07/31/2026
• Initial Report FDA Received Date: 07/10/2026
• Supplement Report FDA Received Date: 08/28/2026
• 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