MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Compliance EndoKit; Accessories, Cleaning Brushes, For Endoscope

Model Number	CEK-746-20
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	06/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3 (date of event): date of event was approximated to 06/01/2026 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: imdrf device code a180104 captures the reportable event of device contamination with chemical or other material.
Event or Problem Description
It was reported to boston scientific corporation that a compliance endokit was being unpacked on an unknown date.Upon opening the product, a live insect was found inside the packaging; therefore, the product could not be used.There was no patient involvement in this event.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 25740355
• Report Number: 3005099803-2026-02705
• Device Sequence Number: 10358481
• Product Code: MNL
• UDI-Device Identifier: 00840253113986
• UDI-Public: (01)00840253113986
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• 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,Followup
• Report Date (Section B): 08/03/2026

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: CEK-746-20
• Device Catalogue Number: CEK-746-20
• 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: 06/19/2026
• Supplement Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 07/07/2026
• Supplement Report FDA Received Date: 08/03/2026
• 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