MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. BRONCHOFIBERSCOPE

Model Number	BF-PE2
Medical Device Problem Codes	Scratched Material (3020); Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to an olympus repair facility, and an evaluation of the device was performed.During the evaluation, the customer's originally reported issue of black spots in the image was confirmed.The following additional findings were also noted: air and a water leak, image guide bundle breakage, dirty bending cover with a cut, connecting tube of the insertion tube has a dent, the bending angle up and down did not meet standard value, scratch on the grip and control unit, electrical contact of eyepiece has a scratch.And control unit has corrosion; due to water leakage.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
A field service engineer reported on behalf of the customer, black spots visible in the image on bronchofiberscope.The customer reported, the issue to be found during maintenance.There were no reports of patient or user harm associated with this event.The device was returned, and olympus repair center found the forceps channel port shaved.This medical device report (mdr) is being submitted to capture the reportable malfunction found during the evaluation of the returned device.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, customer follow-up and correction to b5, g2, h6 (medical device problem code).Correction: b5, g2, h6 (medical device problem code) information was inadvertently not included on the initial medwatch.Customer could not confirm if the device was reprocessed prior to returning the device to repair.The customer stated the following for their cleaning, disinfection, and sterilization (cds) of the scope: there were no malfunction of reprocessing accessories, no delay of pre cleaning or manual cleaning, the surface was wiped during precleaning and manual cleaning, but not the brushing the surface in general practice.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, it is likely that the metal part of endo therapy accessory/cleaning brush interfered with biopsy port during insertion/withdrawal of them and it caused the forceps channel port to be shaved.The cause as to why foreign matter remained in the device could not be identified.The user can detect and prevent the suggested event by handling the device in accordance with the following instructions for use (ifu): bronchofiberscope bf-e2 series chapter 3 preparation and inspection.Bronchofiberscope bf-e2 series chapter 4 operation, chapter 5 reprocessing: general policy.Olympus will continue to monitor field performance for this device.
Event or Problem Description
In addition, the olympus repair center found the bending section cover is dirty.

• Brand Name: BRONCHOFIBERSCOPE
• Common Device Name: BRONCHOFIBERSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16865461
• Report Number: 9610595-2023-07079
• Device Sequence Number: 12127665
• Product Code: EOQ
• UDI-Device Identifier: 04953170062988
• UDI-Public: 04953170062988
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K023984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2023

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: BF-PE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2023
• 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: 04/05/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2021
• 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