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

Model Number BF-1T180

Device Problem Microbial Contamination of Device (2303)

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

Event Date 01/16/2024

Event Type  malfunction  

Manufacturer Narrative

The suspect device has not yet been returned to olympus for evaluation and the investigation is ongoing.The physical device evaluation has not been completed.Prior to the device evaluation, the device was sent out for additional microbiological testing.The microbiological analysis results are pending.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

It was reported that, during reprocessing, the bronchovideoscope's working channel tested positive for coagulase-negative staphylococci and pseudomonas aeruginosa on (b)(6) 2024.The suction channel tested positive for pseudomonas aeruginosa on (b)(6) 2024, and the scope surface tested positive for coagulase-negative staphylococci on (b)(6) 2024.The user did not report any contamination or any other serious deterioration in state of health of any person, to which the scope could have been a contributory cause.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to correct d9 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, the foreign material could not be identified nor the root cause of it.The events can be detected/prevented in accordance with the following instructions for use: ¿failure to properly clean and high-level disinfect or sterilize endoscopic equipment after each procedure may compromise patient safety.To minimize the risk of transmitting diseases from one patient to another, after each procedure the endoscope and its ancillary equipment must undergo thorough manual cleaning followed by high-level disinfection or sterilization as described in chapter 3, ¿cleaning, disinfection, and sterilization procedures¿.Reprocess not only the external surface of the endoscope but also all channels.¿ 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: 18767095
• MDR Text Key: 337078546
• Report Number: 9610595-2024-03828
• Device Sequence Number: 1
• Product Code: EOQ
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

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: 02/05/2024
• Initial Date FDA Received: 02/23/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2018
• 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