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

Model Number	BW-400L
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that there was an issue with the single use single-ended cleaning brush; cannot insert or remove the brush from the balloon channel.There were no reports of patient or user harm associated with this event.The device was returned to olympus for a device evaluation and found the single use single-ended cleaning brush had been damaged/broken and remained in the channel of the scope.No patient or procedure was involved with this event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
Additional Manufacturer Narrative
The device was returned to olympus for a device evaluation and the customer¿s allegation was not confirmed.The device evaluation performed a visual inspection of the received condition and was unable to find any restrictions/issues when inserting the brand-new olympus brush through the suction balloon channel on the scope.However, the customer brush was recovered from the scope case and noticed there are multiple kinks with their cleaning brush.The biopsy channel was inspected with olympus boroscope and observed 2 minor kinks on the biopsy channel wall from the bending section side that cause minor restrictions when tested with olympus brush.Also tested the suction channel with olympus brush and was unable to find any signs of restrictions/blockage with the channel.Recommended customer replaces cleaning brush with an olympus brush.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.Related patient identifier: (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, and since no device malfunction was confirmed during evaluation, the definitive root cause of the reported issue could not be determined.The following information is stated in the instructions for use (ifu): ¿¿when the brush is inserted into the insertion tube side of the endoscope¿s air channel, the brush may tend to bend into a loop after use.This is normal.A kinked brush will not pass smoothly and should be replaced with a new one.¿ olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE SINGLE-ENDED 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: 17647771
• Report Number: 9614641-2023-01257
• Device Sequence Number: 6313725
• Product Code: MNL
• UDI-Device Identifier: 04953170297984
• UDI-Public: 04953170297984
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: CLASS1-EXMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2023

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: BW-400L
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2023
• 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: 07/31/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 09/21/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown