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

Model Number	BW-411B
Medical Device Problem Codes	Break (1069); Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was observed during the device inspection, that the single use combination cleaning brush tip fell off, a broken brush that was stuck within the bronchovideoscope's channel.There were no reports of patient involvement.
Additional Manufacturer Narrative
This supplemental report is being submitted to correct the initial reports awareness date (g3) to 29feb2024.
Event or Problem Description
The issue occurred during a therapeutic guided sheath technique.The intended procedure was completed using a similar device.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Corrected fields: b1 (adverse event is not applicable to this case), b5, e1, e2 and e3.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that the tip of the channel cleaning brush remains in the channel of the scope occurred due the wire was repeatedly bent for some reason, leading to its breakage, since the broken area exhibits the characteristics of brittle fracture.The event can be detected and prevented by handling the device in accordance with the following instructions for use: after using, carefully check that no parts of the brush have fallen off inside the endoscope's suction channel.If this inspection determines that a part or parts of the brush have come off during cleaning, immediately retrieve them by passing a new instrument or other endotherapy accessory through the channel.Any part of the brush remaining in the channel after cleaning can drop into the patient's body during a subsequent procedure.Depending on the location of a detached part, it may not be recoverable by passing a new instrument or other endotherapy accessory through the endoscope's suction channel.In this case, contact olympus.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 withdraw the instrument quickly from the equipment being cleaned.Doing so may cause operator's infection or irritation from the splashes of patient blood/mucus and detergent solution.Exchange this instrument for new one if the brush head is deformed (see figure 4) or the shaft is kinked or deformed (see figure 5).Using a damaged instrument may cause the shaft to be broken, and the broken shaft and/or brush head may remain inside the endoscope¿s channel.Do not withdraw this instrument from the openings of the endoscope at an extreme angle against the insertion direction or with excessive force (see figure 6).Withdraw this instrument slowly with the shaft straight against the insertion direction of the openings of the endoscope (see figure 7,8).Withdrawing the shaft at extreme angel may cause the shaft to be broken and the broken shaft and/or brush head may remain inside the endoscope¿s channel.After withdrawing this instrument from the endoscope, check that there are no abnormities of the brush.This instrument is intended for single use.Do not attempt to use this instrument to clean multiple endoscopes.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: 19116541
• Report Number: 9614641-2024-00920
• Device Sequence Number: 7576040
• Product Code: MNL
• UDI-Device Identifier: 04953170297410
• UDI-Public: 04953170297410
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: CLASS1-EXMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BW-411B
• Device Lot Number: 17V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/22/2024
• Supplement Date Received by Manufacturer: 05/22/2024; 06/20/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 05/23/2024; 06/24/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: K-201- SINGLE USE BF-P290 - BONCHOVIDEOSCOPE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown