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

Model Number BF-1T180

Device Problems Melted (1385); Microbial Contamination of Device (2303); Excessive Heating (4030)

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

Event Date 08/29/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, after reprocessing, the evis exera ii bronchovideoscope tested positive for coagulase-negative staphylococci.The suction channel and working channels were sampled.The endoscope was not in use with positive culture results.The user did not report any contamination or any other serious deterioration in the state of health of any person, to which the scope could have been a contributory cause.

Manufacturer Narrative

Prior to device evaluation, the olympus scope was sent to an independent laboratory for culture testing.The hygiene microbiological investigation report indicated the distal end and instrument/biopsy/suction channels of the scope were cultured and there was no detection for microorganisms.Overall, the results are in conformance with the requirements.To date, the device has not been returned to olympus for evaluation.Additional information has been requested regarding this event.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information becomes available.

Manufacturer Narrative

Correction to h6 of the first supplemental report: for "component code" information was incorrectly added on the first supplemental report.The correct code is 841 - imager, submitted on the initial report.- for "medical device problem code" information was incorrectly added on the first supplemental report.- for "investigation findings" information was incorrectly added on the first supplemental report.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, the device evaluation results, and further information provided by the customer.Additionally, (d9) returned to manufacturer date was added, (h3) device evaluated by manufacturer was updated to yes.(h4) device manufacturer date was added.The device was returned to olympus and the evaluation found the distal end and cover of the probe were burnt.According to the customer, pre-cleaning takes place immediately after the examination and includes the following: wiping the outer surface of the endoscope with a gauze pad.Suctioning the working channel with distilled water.Suctioning the working channel with cidezyme solution.Johnson & johnson cidezyme enzymatic detergent is used.The liquid used for manual cleaning is changed several times a day.A maximum of three endoscopes are washed in one dose.The leakage test is performed after every intervention, before manual cleaning, with an olympus mu-1 model leak tester.The working channel of the endoscope is cleaned with a disposable cleaning brush (olympus n3640850 - bw-412t single-use cleaning brush).Two olympus mini etd2 plus paa, automatic endoscope reprocessors are used (serial numbers: (b)(6) ).In case of any problems, both machines are checked by the anamed company.The last preventive maintenance on the devices were done in 2023 (19943478 28jun2023 and 19943488 on 15sep2023).The disinfectant solutions used with the endoscope are by ecolab (endodis, endoact, endodet).The minimum effective concentration is checked at each wash.According to the manufacturer's specifications, maintenance is carried out every 2000 operating hours.The last reprocessing in-services conducted by an olympus endoscopy support specialist were: with serial number (b)(6) on 28jun2023.With serial number (b)(6) on 15sep2023.Neither the staff nor the facilities have changed since the last visit and all personnel have received the training.Endoscopes are stored in a separate room, in an iron cabinet, hung up.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 8 years since the subject device was manufactured.Issue 1 - based on the results of the investigation and the information provided, the cause of the positive culture test reported could not be determined.There were no deviations identified with the reprocessing performed.Issue 2 - based on the results of the investigation and the information provided, the cause of the burnt distal end and cover of the probe could not be conclusively determined.However, the user may have used high energy endo therapy accessories without distancing the tip of the accessory from distal end of the device.The event can be detected/prevented by following the instructions for use (ifu): issue 1.Bf type p180/q180/1t180/1tq180 operation manual provides the following warning ¿after using this instrument, reprocess and store it according to the instructions given in the endoscope¿s companion ¿reprocessing manual¿ with your endoscope model listed on the cover.Using improperly or incompletely reprocessed or stored instruments may cause patient cross-contamination and/or infection.¿.Issue 2.Bf type p180/q180/1t180/1tq180 operation manual chapter 3 preparation and inspection and chapter 4 operation 4.2 using endotherapy accessories.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II 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: 18131018
• MDR Text Key: 328043878
• Report Number: 9610595-2023-17141
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170339325
• UDI-Public: 04953170339325
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: K061313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2024

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
• Device Operator: Health Professional
• Device Model Number: BF-1T180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/18/2023
• Initial Date FDA Received: 11/14/2023
• Supplement Dates Manufacturer Received: 01/18/2024; 01/24/2024
• Supplement Dates FDA Received: 01/23/2024; 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/25/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0191-2024
• Patient Sequence Number: 1