MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA BRONCHOVIDEOSCOPE

Model Number	BF-XT160
Medical Device Problem Code	Melted (1385)
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, it was discovered that the plastic distal end cover of the device had a burned mark.The customer's originally reported issue of inability to reprocess was not confirmed.The following additional findings were also noted: bending section cover glue separated, angulation was below the specified value, and angulation play.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported that they could not reprocess their evis exera bronchovideoscope device due to unspecified reasons.Upon the receipt and inspection of the returned device on 14oct2023, it was discovered that the plastic distal end cover was burned.There were no reports of patient or user harm associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
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, it is likely that while handling the subject device, the user used a high energy endo therapy accessory, such as laser and high frequency, without keeping enough distance from the distal end of the subject device; as a result, the c-cover was burnt.However, a definitive root cause could not be determined.User may be able to detect the suggested event by handling device in accordance with the following instructions for use (ifu) bf type 160 series operation manual chapter 3 "preparation and inspection" ifu provides the points of attention for use of high-energy endo therapy accessories in ¿bf type 160 series operation manual chapter 4 "operation" 4.2 using endo-therapy accessories¿ olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA BRONCHOVIDEOSCOPE
• Common Device Name: BRONCHOVIDEOSCOPE
• 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: 18126964
• Report Number: 9610595-2023-17092
• Device Sequence Number: 7581550
• Product Code: EOQ
• UDI-Device Identifier: 04953170340147
• UDI-Public: 04953170340147
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2023

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-XT160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2023
• 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: 10/14/2023
• Supplement Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2015
• 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