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

Model Number	SBD-291-50
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is a non-sterile device with no expiration date.Imdrf device code a0401 captures the reportable event of white ball tip scraped off.
Event or Problem Description
It was reported to boston scientific corporation that a hedgehog sweeper brush was used during a scope cleaning on (b)(6) 2024.During scope cleaning, the white ball tip attached to the tip brush was scraped off.It was removed from the scope.The scope cleaning was completed using another of the same device.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 white ball tip scraped off.Block h11: investigation results the returned hedgehog sweeper brush was analyzed.Visual evaluation found that the device did not demonstrate any issues.No damage or defect was noted with the components of the hedgehog device and both ball tips were present on the brushes.Based on all available information and analysis of the returned device, the most probable cause is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that a hedgehog sweeper brush was used during a scope cleaning on (b)(6) 2024.During scope cleaning, the white ball tip attached to the tip brush was scraped off.It was removed from the scope.The scope cleaning was completed using another of the same device.There was no patient involvement in this event.

• 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: 19872410
• Report Number: 3005099803-2024-03505
• Device Sequence Number: 7627717
• Product Code: MNL
• UDI-Device Identifier: 00816849016443
• UDI-Public: 00816849016443
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

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: SBD-291-50
• Device Catalogue Number: 60252
• Device Lot Number: 0000231221
• 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: 07/02/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 07/31/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/26/2023
• 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