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

Model Number	BF-Q180
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reference device was returned.No evaluation can be performed because the device was obsolete.The investigation is ongoing; therefore, the root cause of the reported malfunction cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
It was reported that a-rubber was blown off the distal end of a evis extera ii bronchovideoscope during reprocessing.There was no patient involvement, no harm or user injury reported due to the event.
Additional Manufacturer Narrative
This follow up report is being submitted to include the device history record(dhr) review , evaluation notes and results from the legal manufacturer investigation.The legal manufacturer performed the dhr review for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.Upon evaluation of the device, the bending cover section damage was confirmed.Furthermore, electrical connector pin leak was noted.The probable cause of the bending section cover blown off the distal end is due to external stress impact such bumping, dropping or interference with sharp objects.As a result, damage was caused to the bending section cover which led to the reported event.In addition, the bending section cover was ruptured because the user performed ethylene oxide gas sterilization of the device with the waterproof cap on.When the leak test was conducted, the inside of the device was over-pressurized, contributing to the rupture of the bending section cover.The instructions for use (ifu) states: do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.Reprocessing manual: 3.8 sterilization: ethylene oxide gas sterilization: if ethylene oxide gas sterilization is performed while the water-resistant cap is attached, the covering of the bending section can be damaged.Olympus will continue to monitor complaints for this device.

• 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: 11694693
• Report Number: 8010047-2021-05158
• Device Sequence Number: 17048176
• Product Code: EOQ
• UDI-Device Identifier: 04953170339301
• UDI-Public: 04953170339301
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K061313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

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: Health Professional
• Device Model Number: BF-Q180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1