MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II BRONCHOVIDEOSCOPE

Model Number	BF-Q180-AC
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and a device evaluation completed for it.Manufacture date is not known.The user¿s complaint was confirmed.Upon inspection and testing of the device, it was observed that the white glue at the channel opening, at the distal end plastic cover, was peeling.Other incidental observations were a slow leak at the forceps passage, some black dots and intermittent flicker of image with manipulation of the light guide tube, dent on the insertion tube, and a bump on the bending section.Evaluation is ongoing.Supplemental report(s) will be filed as any information becomes available.
Event or Problem Description
As reported for this event, the device had some peeling through the distal channel.There is no reported harm to any patient.
Additional Manufacturer Narrative
There is additional information for the event.This supplemental report is being submitted to provide this information.Please see the updates in sections: g3, g6, h2, and h10.The facility sterile processing department (spd) has started using a borescope since (b)(6) 2020.When tears or black spots are observed on the device, the device is sent in for repairs.
Additional Manufacturer Narrative
There is more information on the device evaluation.This supplemental report is being submitted to provide this information.The device history record review confirmed that device was shipped in accordance with specifications.The subject device was not repaired within the past one year.The cause of the event cannot be conclusively specified.The distal end plastic cover (c-cover) was possibly damaged due to insertion and withdrawal of endo therapy accessories while the bending section was being angulated.The steps may have been as follows: a) endo therapy accessories were inserted and withdrawn while the bending section was being angulated.B) at that time, endo therapy accessories interfered with c-cover (biopsy channel opening).C) the part of c-cover which interfered with the endo therapy accessories was damaged.

• Brand Name: EVIS EXERA II BRONCHOVIDEOSCOPE
• Common Device Name: BRONCHOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11670247
• Report Number: 8010047-2021-04977
• Device Sequence Number: 11538235
• Product Code: EOQ
• UDI-Device Identifier: 04953170340086
• UDI-Public: 04953170340086
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K050220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2021

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: No Information
• Device Model Number: BF-Q180-AC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 04/21/2021; 06/03/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 05/12/2021; 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1