MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COMPLIANCE ENDOKIT; ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE

Model Number	CEK-1876-20
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a180104 captures the reportable event of presence of foreign material in the device.
Event or Problem Description
It was reported to boston scientific corporation that a compliance endokit was being prepared for a procedure performed on (b)(6) 2025.During preparation, the technician retrieved an endo compliance kit and observed a worm-like insect, resembling a mealworm, inside the clear plastic wrapping surrounding the green kit.They chose not to use the affected kit and set it aside; out of concern for potential contamination.The procedure was completed with another compliance endokit.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a compliance endokit was being prepared for a procedure performed on (b)(6) 2025.During preparation, the technician retrieved an endo compliance kit and observed a worm-like insect, resembling a mealworm, inside the clear plastic wrapping surrounding the green kit.They chose not to use the affected kit and set it aside, out of concern for potential contamination.The procedure was completed with another compliance endokit.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Additional information: block g2 (report source) and block h10 (related report number).Block h6: imdrf device code a180104 captures the reportable event of presence of foreign material in the device.

• Brand Name: COMPLIANCE ENDOKIT
• Common Device Name: ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 11480 lakefield dr; johns creek GA 30097
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22860735
• Report Number: 3005099803-2025-04120
• Device Sequence Number: 9339422
• Product Code: MNL
• UDI-Device Identifier: 00191506034801
• UDI-Public: (01)00191506034801(17)270401(10)36823946
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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: CEK-1876-20
• Device Catalogue Number: 2088-21
• Device Lot Number: 0036823946
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 09/03/2025
• Date Device Manufactured: 04/14/2025
• 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