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	07/21/2026
Type of Reportable Event	Malfunction

• 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; changzhou, 100, 21320 0; CH 213200
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 50488964
• Report Number: 3005099803-2026-03492
• Device Sequence Number: 10592866
• Product Code: MNL
• UDI-Device Identifier: 00816849010090
• UDI-Public: (01)00816849010090(11)260114(10)260102
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: SBD-289-50
• Device Lot Number: 0000260102
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 08/28/2026
• 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