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

Model Number	BF-N20
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported with an issue of air/water leakages.The issue was found during reprocessing.There was no patient harm, no user injury reported due to the event.Device evaluation found there is a missing part (distal end ) of the scope.This report is being submitted for missing part of the scope (distal end) which was noted during device evaluation.
Additional Manufacturer Narrative
Device return evaluation was completed.The customer complaint was confirmed.Device inspection found an air leak at bending tube.Additionally, service repair noted there is a missing part (distal end) of the endoscope.The defect was caused by customers handling.Furthermore, the following findings during inspection were noted on the device: light guide (lg)-cover glasses has scratch, image guide (ig) -cover glasses has scratch, light balance illumination noted broken fibers, a-rubber glue (bending section) has gap, grip unit painting peel off, up down plate peeling off.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 the bending section was physically stressed such as being caught in a door or a lid of a reprocessor, causing he suggested event.Olympus will continue to monitor field performance for this device.

• Brand Name: OES 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 Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15229379
• Report Number: 9610595-2022-00900
• Device Sequence Number: 6456033
• Product Code: EOQ
• UDI-Device Identifier: 04953170051142
• UDI-Public: 04953170051142
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K910423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2022

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-N20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2022
• Supplement Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2019
• 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