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

Model Number	M00545261
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h6: imdrf device code a0501 captures the reportable event of the sponge detached.Block h11: investigation results: the device was not returned for analysis.However, based on the photo provided by the customer it can be observed the label information of the device and the sponge detached from the device.Therefore, the sponge detachment is confirmed.Based on the available information, the most likely cause of the reported issue of sponge detachment cannot be determined due to insufficient evidence.The product was not returned for analysis, preventing any assessment of potential defects.Although the customer submitted a photo showing the device label and the detached sponge, the absence of a thorough evaluation means the underlying factors contributing to the issue remain unknown.Therefore, the most probable cause is cause not established.A risk review was completed and confirmed that the event of "sponge detachment of device or device component" was defined in the risk documentation and is documented accordingly in the prr.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.
Event or Problem Description
It was reported to boston scientific corporation that an rx locking device and biopsy cap was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.During the procedure, the sponge within the biopsy cap detached and was lodged in the scope.It was removed in the cleaning room.The procedure was completed with a new scope and rx locking device.There were no patient complications reported as a result after this event.

• Brand Name: RX LOCKING DEVICE AND BIOPSY CAP
• 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: 24756343
• Report Number: 3005099803-2026-01182
• Device Sequence Number: 13036717
• Product Code: ODC
• UDI-Device Identifier: 08714729296614
• UDI-Public: (01)08714729296614(17)280604(10)36686422
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/01/2026

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: M00545261
• Device Catalogue Number: 4526
• Device Lot Number: 0036686422
• 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: 03/05/2026
• Initial Report FDA Received Date: 04/01/2026
• Date Device Manufactured: 06/05/2025
• 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