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

Model Number	BF-P60
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that the oes bronchofiberscope insertion tube skin was damaged.The issue was found during preparation for use for a diagnostic bronchoscopy which was completed with a similar device.There were no reports of patient harm.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found the insertion tube coating was peeling off with metal inside the insertion section exposed.In addition to the reportable malfunction, the following were noted: switch 1 and the image guide protector were damaged; the light guide lens had a crack; the connecting tube had snaking; there were many black dots and red cracks in the image; the control section had corrosion and crystals internally; there was no angulation; the eyepiece was worn.A review of device history record and historical complaints analysis was conducted and no deviations that could have caused or contributed to the reported issue was identified.Based on the results of the investigation, physical stress was applied to the insertion section during user handling and caused the coating to peel.This issue is addressed in the instructions for use (ifu): "3.2 inspection of the endoscope 5.Inspect the external surface of the entire insertion tube including the bending section and the distal end for dents, bulges, swelling, peeling, scratching, holes, sagging, transformation, bends, adhesion of foreign body, dropout of parts, any protruding objects or other irregularities." olympus will continue to monitor the field performance of 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 (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18088913
• Report Number: 9610595-2023-16658
• Device Sequence Number: 12224107
• Product Code: EOQ
• UDI-Device Identifier: 04953170308123
• UDI-Public: 04953170308123
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K023984
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/07/2023

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-P60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2023
• Initial Report FDA Received Date: 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2011
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OTV-S190 VISERA ELITE VIDEO SYSTEM
• Patient Sex: Unknown