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

Model Number BF-P190

Device Problem Microbial Contamination of Device (2303)

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

Event Date 11/28/2023

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 and results are still pending.The investigation is ongoing and follow up with the customer is currently being performed.After culture testing, the device will be evaluated.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

It was reported that, during reprocessing, the bronchovideoscope tested positive for 6 colony forming units (cfus) of micrococcus luteus and 22 colony forming units (cfus) of paracoccus yeei.All channels were sampled.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 device evaluation.The device was returned, and the evaluation found white residue was attached inside insertion section mount / mouth guard piece for endoscopy.It was not possible to identify when the foreign material had been attached to the subject device.Additionally, the following findings were observed during testing and inspection: connector plug unit leak; bending section cover glue separated; insertion section mount/mouth guard piece damaged; suction cylinder damaged; and distal end/biopsy channel cuts.The hygiene microbiological investigation report indicated the channels of the scope were cultured and tested positive for <1 colony forming units (cfus) of bacteria.The results obtained comply with the target level for an endoscope subjected to high level disinfection and rinsed with sterile water.The investigation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

This report is being supplemented to provide additional information based on results of third-party testing, the customer provided cleaning disinfection and sanitization (cds) practices, the device evaluation, and the legal manufacturer's final investigation.Olympus provided the following result of the culture test, performed at the third-party labs: sampling date: (b)(6) 2024; sampling from: all channels; cfu: <1cfu; bacterial identification: n/a.Upon review of the cleaning disinfection and sterilization practices (cds) provided by the user, no deviations from the ifu were identified.The device was evaluated and damage was observed at the insertion section mount/mouth guard piece location where bacteria were detected that may have contributed to the positive culture.A review of the device history record found no deviations that could have contributed to the reported issue.Based on the results of the investigation, a root cause could not be determined.Growth of microorganisms were found through culture testing by the user after reprocessing, however, when olympus culture tested after reprocessing in accordance with instructions for use (ifu) before repair, the results conformed to the regulation's recommendation.The reported micrococcus and paracoccus are organisms that can be found in the environment, which could suggest that there was a cross contamination during sampling.The detected organisms are classic examples of contamination while sampling, which is further supported by a lack of indicator organisms associated with bronchoscopy.Additionally, the foreign material observed in the insertion section mount/mouth guard piece appeared to be a white residue but otherwise could not be identified.A definitive root cause of the issue could not be determined, however, due to the observed device damage, the observed residue may not have been removed during cleaning/reprocessing.The following is included in the device ifu: "an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them." 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: 18640480
• MDR Text Key: 336059133
• Report Number: 9610595-2024-02421
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K201758
• 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: 03/11/2024

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-P190
• 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: 01/10/2024
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 03/11/2024
• Supplement Dates FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2020
• 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