MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RX LOCKING DEVICE; ENDOSCOPE CHANNEL ACCESSORY

Model Number	M00545211
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
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: imdrf device code a0501 captures the reportable event of the sponge detachment.Block h11: the product was not returned for analysis; therefore, a technical analysis could not be performed to identify any defect with the device.Without a product returned, no product analysis could be conducted.A media inspection was performed to the photo provided by the customer where it can be observed the sponge detached from the cap.However, without proper evaluation of the device, it remains unknown the most probable causes that contributed to the events.With all the available information boston scientific concludes that the reported event of sponge detachment was confirmed.Based on the information provided, the most probable cause of the reported problems cannot be established due to lack of evidence.All compiled information on this investigation determines that the most probable cause is cause not established.
Event or Problem Description
It was reported to boston scientific corporation that rx locking / biopsy cap was used during a procedure performed on (b)(6) 2025.During the procedure, the sponge of the biopsy cap detached and become lodged in the scope's biopsy channel as an accessory device was pushed through.The scope was sent for repair to remove the sponge.There were no patient complications reported as a result after this event.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.

• Brand Name: RX LOCKING DEVICE
• 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; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23858886
• Report Number: 3005099803-2025-06809
• Device Sequence Number: 10116167
• Product Code: ODC
• UDI-Device Identifier: 08714729440604
• UDI-Public: (01)08714729440604
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K010610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/20/2025

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: M00545211
• Device Catalogue Number: 4521
• 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: 11/26/2025
• Initial Report FDA Received Date: 12/20/2025
• 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