MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OrcaPod?; pump, air, non-manual, for endoscope

Model Number	SUV-629
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Material Integrity Problem (2978); Physical Resistance/Sticking (4012)
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 orca valve was used during a colonoscopy procedure performed on an unknown date.During the procedure, the red suction button became stuck in the depressed position and did not return to its standard position.Attempts to remove and replace the suction button were unsuccessful, and a hemostat was required to extract the device.The procedure was completed using another orca suction button of the same type.Following the procedure, the endoscope was sent for repair.Upon return of the scope, facility personnel performed a functional test and observed that the suction button could not be properly seated in the suction port.Further inspection of the suction well revealed a broken fragment of the suction button shaft lodged within the port.No visible damage had been identified at the time of the original procedure, and the shaft fracture was not recognized until the subsequent inspection.The issue was isolated to the red suction button; the blue air/water button was not involved.No patient complication was reported as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block d2b: subsequent pro codes ocx, odc.Block d4, h4: the complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.Block h6: imdrf device code a0509 captures the reportable event of suction button sticking.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 50714637
• Report Number: 3005099803-2026-03696
• Device Sequence Number: 10598766
• Product Code: FEQ
• UDI-Device Identifier: 08714729981572
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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
• Device Catalogue Number: SUV-629
• 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: 08/20/2026
• Initial Report FDA Received Date: 09/10/2026
• 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