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

Model Number	SBD-228-50
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a hedgehog double-end brush was used on an unknown date.During scope cleaning, the brush part came off.There was no patient involvement with this event.
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block d4 and h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: device code a0401 captures the reportable event of brush break.Block h10: investigation results: the returned hedgehog double-end brush was analyzed.Visual evaluation found that both small brush heads were missing bristles.No other problems were noted.The reported event was confirmed.Product analysis identified that both small brush heads were missing bristles.It is possible for bristles to become dislodged if the brush is twisted or torqued while inside the scope, opposite the direction in which the bristles are twisted onto the shaft during assembly.Breaking of bristles can also occur if the brush is forced into the scope.According to the instructions for use (ifu) excessive twisting or torquing is not recommended.Based on all available information and analysis of the returned device, the most probable cause is unintended use error caused or contributed to event, indicating that the interaction between the user and device caused or contributed to the event.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a hedgehog double-end brush was used on an unknown date.During scope cleaning, the brush part came off.There was no patient involvement with 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): SUZHOU TEMEIRUL MEDICAL PRODUCTS CO; no 699 pinan road puzhuang; linhu to; suzhou, 100 21510 5; CH 215105
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16013552
• Report Number: 3005099803-2022-07582
• Device Sequence Number: 7334638
• Product Code: MNL
• UDI-Device Identifier: 00816849010083
• UDI-Public: 00816849010083
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2023

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-228-50
• Device Catalogue Number: 60252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2022
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 02/23/2023
• 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