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

Model Number	SBD-289-50
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a hedgehog double-end brush head was found in a scope's suction channel during scope cleaning on (b)(6) 2025.During scope cleaning, the nurse found a broken tip of the brush inside the scope's suction channel near the area where the cap is placed.Upon inspection, she illuminated the inside of the scope, noticed the white part of the brush, and successfully retrieved it.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
Block d4, h4: the complainant was unable to provide a lot number.Therefore, the manufacture date is unknown.Block d4: this is a non-sterile device with no expiration date.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 during a colonoscopy and esophagogastroduodenoscopy (egd) procedures performed on (b)(6) 2025.During the procedure, the nurse found a broken tip of the brush inside the scope.It had detached and was located in the suction channel, near the area where the cap is placed.Upon inspection, she illuminated the inside of the scope; noticed the white part of the brush and successfully retrieved it.There were no reported patient complications as a result of 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.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide a lot number.Therefore, the manufacture date is unknown.Block d4: this is a non-sterile device with no expiration date.Block h6: imdrf device code a0401 captures the reportable event of brush broken/fractured.Block bh11: correction to block b5 (describe event or problem).
Additional Manufacturer Narrative
Additional information: block e1 (initial reporter email).Block d4, h4: the complainant was unable to provide a lot number.Therefore, the manufacture date is unknown.Block d4: this is a non-sterile device with no expiration date.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 during a colonoscopy and esophagogastroduodenoscopy (egd) procedures performed on (b)(6) 2025.During the procedure, the nurse found a broken tip of the brush inside the scope.It had detached and was located in the suction channel, near the area where the cap is placed.Upon inspection, she illuminated the inside of the scope; noticed the white part of the brush and successfully retrieved it.There were no reported patient complications as a result of 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.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide a lot number.Therefore, the manufacture date is unknown.Block d4: this is a non-sterile device with no expiration date.Block h6: imdrf device code a0401 captures the reportable event of brush broken/fractured.Block h11: investigation results: the product was not returned for analysis.However, a media inspection was performed based on a photo provided by the customer.The image shows that the brush head was detached.Therefore, the reported allegation has been confirmed.With all the available information, boston scientific concludes the reported event was confirmed.According to the media analysis performed, the brush head was detached.The investigation findings and all information available concludes the most probable root cause is a cause not established since the investigation findings do not lead to a clear conclusion about the cause of the reported event.An investigation to identify the root cause of hedgehog brush breaks is in progress, including brush breaks near the joint with the green handle.
Event or Problem Description
It was reported to boston scientific corporation that a hedgehog double-end brush was used during a colonoscopy and esophagogastroduodenoscopy (egd) procedures performed on (b)(6) 2025.During the procedure, the nurse found a broken tip of the brush inside the scope.It had detached and was located in the suction channel, near the area where the cap is placed.Upon inspection, she illuminated the inside of the scope; noticed the white part of the brush and successfully retrieved it.There were no reported patient complications as a result of 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: 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: 23167854
• Report Number: 3005099803-2025-04970
• Device Sequence Number: 13171578
• Product Code: MNL
• UDI-Device Identifier: 00816849010090
• UDI-Public: (01)00816849010090
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/20/2025

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: SBD-289-50
• Device Catalogue Number: 60252
• 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: 09/05/2025
• Supplement Date Received by Manufacturer: 09/15/2025; 10/10/2025; 10/30/2025
• Initial Report FDA Received Date: 09/29/2025
• Supplement Report FDA Received Date: 10/08/2025; 10/30/2025; 11/20/2025
• 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