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

Model Number	SBD-289-50
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to report the lot number; therefore, the manufacture date is unknown.This is a non-sterile device with no expiration date.Block e1 (initial reporter facility name): the cancer institute hospital of japanese foundation for cancer research ariake hospital block h6: imdrf device code a0401 captures the reportable event of brush broken/fractured.
Event or Problem Description
It was reported to boston scientific corporation that a hedgehog double-end brush was used on (b)(6) 2025.During scope cleaning, the hedgehog brush head was damaged at the connection point to the valve brush.The scope cleaning was completed using another of the same device.There was no patient involvement in the 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.
Additional Manufacturer Narrative
Additional information: block b5 (describe event or problem).Block d4, h4: the complainant was unable to report the lot number; therefore the manufacture date is unknown.This is a non-sterile device with no expiration date.Block e1 (initial reporter facility name): (b)(6).Block h6: imdrf device code a0401 captures the reportable event of brush broken/fractured.
Event or Problem Description
It was reported to boston scientific corporation that a hedgehog double-end brush was used on (b)(6) 2025.During scope cleaning, the hedgehog brush head was damaged at the connection point to the valve brush.The scope cleaning was completed using another of the same device.There was no patient involvement in the 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.Additional information was received on november 18, 2025: it was reported that at the time of retrieval, the hedgehog double-end brush was found broken into two pieces.The break occurred during cleaning, outside the endoscope, at the connection point between the brush head and the valve brush.
Additional Manufacturer Narrative
Additional information: block b5 (describe event or problem).Block d4, h4: the complainant was unable to report the lot number; therefore the manufacture date is unknown.This is a non-sterile device with no expiration date.Block e1 (initial reporter facility name): (b)(6).Block h6: imdrf device code a0401 captures the reportable event of brush broken/fractured.Block h11: one hedgehog brush was received for analysis in two separate pieces.The valve brush was detached and returned.Visual inspection confirmed that the brush head had separated from the green-handle end of the dual brush.No additional damage or defects were observed.Product analysis confirmed the reported event of a detached brush head.Therefore, a review and analysis of all available information indicated the most probable cause is "cause linked to device but unable to trace more specifically." an investigation to address this problem is currently in progress.A review of the manufacturing documentation for this device was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots, and a manufacturing review of the most probable lots did not identify any anomalies or deviations that could have contributed to the event.
Event or Problem Description
It was reported to boston scientific corporation that a hedgehog double-end brush was used on (b)(6) 2025.During scope cleaning, the hedgehog brush head was damaged at the connection point to the valve brush.The scope cleaning was completed using another of the same device.There was no patient involvement in the 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.Additional information was received on november 18, 2025: it was reported that at the time of retrieval, the hedgehog double-end brush was found broken into two pieces.The break occurred during cleaning, outside the endoscope, at the connection point between the brush head and the valve brush.

• Brand Name: HEDGEHOG
• Common Device Name: ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): CHANGZHOU TEMEIRUI MEDICAL; building 34 no 249; middle liangchan; changzhou, 100 21320 0; CH 213200
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23593696
• Report Number: 3005099803-2025-06160
• Device Sequence Number: 9868784
• Product Code: MNL
• UDI-Device Identifier: 00816849010090
• UDI-Public: (01)00816849010090
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/30/2026

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: SBD-289-50
• Device Catalogue Number: 60252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 11/18/2025; 03/02/2026
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 12/17/2025; 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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