MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. CLEANING BRUSH

Model Number	MAJ-1534
Medical Device Problem Codes	Device Reprocessing Problem (1091); Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The endoscopy support specialist reported to olympus that the cleaning brush that was used during cleaning of the linear eus scopes, was not recommended by olympus.The facility used a patient toothbrush for cleaning and stated that they made an infection prevention decision to move away from using the maj-1534 cleaning brush because they did not want to use any reusable brushes.The registered nurse was advised that the cleaning steps were outside of the instruction for use (ifu) from olympus.The issue was found during a demonstration at an in-service visit.There were no reports of patient harm.
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation as the customer did not have the brush.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

• Brand Name: CLEANING BRUSH
• Common Device Name: 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17455217
• Report Number: 9614641-2023-01084
• Device Sequence Number: 12584978
• Product Code: LFL
• UDI-Device Identifier: 04953170208485
• UDI-Public: 04953170208485
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K042160
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/03/2023

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: MAJ-1534
• Device Lot Number: UNKNOWN
• 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: 07/11/2023
• Initial Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2019
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown