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

Model Number	SBB-382-50
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a hedgehog double-end brush was used during a scope cleaning on (b)(6) 2024.During scope cleaning, the bristles on one side of the double end brush broke.The bristles were not removed from the scope.The scope cleaning was completed using another hedgehog brush.There was no patient involvement in this event.
Additional Manufacturer Narrative
Block d4: this is a non-sterile device with no expiration date.Block h6: imdrf device code a0401 captures the reportable event of brush break.
Event or Problem Description
It was reported to boston scientific corporation that a hedgehog double-end brush was used during a scope cleaning on (b)(6) 2024.During scope cleaning, the double end brush bristles were broken on one side.The bristles were not removed from the scope.The scope cleaning was completed using another hedgehog brush.There was no patient involvement in this event.
Additional Manufacturer Narrative
Block d4: this is a non-sterile device with no expiration date.Block h6: imdrf device code a0401 captures the reportable event of brush break.Block h10: investigation results the returned hedgehog was analyzed.Visual evaluation found that the channel brush was detached from the working length due to a clean cut.No other problems were noted.The reported event was confirmed.It is possible that the interaction between the cleaning brush and scope caused the observed failure.The dfu warns against excessive force/torque that may cause the brush head to detach from the working length.Based on all available information and analysis of the returned device, the most probable cause is unintended use error caused or contributed to event.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20009168
• Report Number: 3005099803-2024-03931
• Device Sequence Number: 7258246
• Product Code: MNL
• UDI-Device Identifier: 00816849016900
• UDI-Public: 00816849016900
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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: SBB-382-50
• Device Catalogue Number: 60252
• Device Lot Number: 0000231013
• 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: 07/24/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2023
• 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