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

Model Number BF-P190

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus and evaluated.The customer¿s allegation was confirmed when fluid invasion was found in the bending section and it was stuck in the angulation position.Additionally, the evaluation found the following non-reportable malfunction(s): charged coupled device lens unit was scratch; light guide lens unit was discoloration; connecting tube was worn; suction channel mouthpiece was worn; universal cord was worn; scope connector cover unit was leaked and rusty; plug unit was rusty.The investigation is ongoing and follow-up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus they had difficulties controlling the bronchovideoscope bending section and removing it from the patient during a diagnostic bronchoscopy.The procedure was completed using the same device.There was no report of patient injury or medical intervention associated with this event.

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 for phenomenon one, it is likely that the angulation difficulty occurred due to following: water likely invaded the insertion section, then the a-wire (angulation wire) slid abnormally in coil-pipe due to corrosion.When the up/down lever was free, bending section was bent.It is likely that the a-wire was stuck.The event can be prevented by following the instructions for use (ifu) which state: "¿ never insert or withdraw the insertion section abruptly or with excessive force.Patient injury, bleeding, and/or perforation may result." based on the results of the investigation for phenomenon two, it is likely that the mouthpiece was deteriorated due to it being shaved by the coiled shaft of channel cleaning brush, scrabbing the mouthpiece.The event can be prevented by following the instructions for use (ifu): operation manual chapter 3 preparation and inspection 3.3 inspection of the endoscope olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III BRONCHOVIDEOSCOPE
• Type of Device: 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: 18316023
• MDR Text Key: 330355276
• Report Number: 9610595-2023-19426
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170434983
• UDI-Public: 04953170434983
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: K201758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-P190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1