MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE COMBINATION CLEANING BRUSH; SINGLE USE SINGLE-ENDED CLEANING BRUSH

Model Number	BW-412T
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported, that when using the single use combination cleaning brush.An endoscope with insufficient reprocessing was used.The issue occurred, during an unspecified procedure.There were no reports of patient or user harm associated with this event.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information based on the legal manufacturer's final investigation.Correction: h6 (component code).The device was not returned to olympus for inspection, therefore, the condition of the device could not be confirmed.Based on the results of the investigation, the presumed cause could not be determined as the device was discarded.In addition, the root cause could not be determined.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported issue.The events can be detected and prevented in accordance with the following sections of the instructions for use (ifu): before use, inspect the entire instrument for any irregularity and the bristles for any damage.Using a brush with irregularities and/or damage can impair its cleaning ability, which may cause infection of the patient.If the bristles are crushed, gently straighten them with your fingers.Clean only one endoscope with this instrument and discard the brush immediately after use.Otherwise, the cleaning effectiveness of the instrument may be impaired, equipment damage and/or infection of the patient and/or operator may occur.Do not attempt to clean, disinfect or sterilize the instrument for reuse.Doing so may damage the instrument and/or the equipment being cleaned, and/or impair its cleaning ability, which may cause infection of the patient.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE COMBINATION CLEANING BRUSH
• Common Device Name: SINGLE USE SINGLE-ENDED CLEANING BRUSH
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20204826
• Report Number: 9614641-2024-01818
• Device Sequence Number: 6674676
• Product Code: MNL
• UDI-Device Identifier: 04953170297427
• UDI-Public: 04953170297427
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXMPT
• 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,User Facility
• Initial Reporter Occupation: Nurse
• 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: BW-412T
• Device Lot Number: ¿¿
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DUODENOVIDEOSCOPE (TJF-Q290V). SERIAL NO. (B)(6)
• Patient Sex: Unknown