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

Model Number BF-P190

Device Problems Melted (1385); Microbial Contamination of Device (2303)

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

Event Date 11/28/2023

Event Type  malfunction  

Event Description

It was reported that, during reprocessing, the bronchovideoscope tested positive for 4 colony forming units (cfus) of staphylococcus capitis.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

The suspect device has 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.The customer provided the cleaning sterilization and disinfection (cds) processes performed at the user facility.The customer did confirm that there were no deviations or deficiencies concerning reprocessing of the scope.Additionally, the customer confirmed that there were no suspected patient infections due to the facility findings.The customer did not provide the specific steps taken during the cleaning sterilization and disinfection (cds) process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Manufacturer Narrative

Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide the results of microbial testing and device evaluation.New information added to the following fields: h6, h10.The microbiological analysis report indicated that an all channel sample was collected on (b)(6) 2024.The results reported conform to results of <1 cfu/100 ml and <1 cfu/endoscope (microorganism revivable).The results obtained comply with the target level defined in instruction dgos/pf2/dgs/vss1/2016/220 of july 4, 2016.During device evaluation at olympus, it was found that the distal end cap was burned.The bending section cover was pierced and leaky.The inner surface of the biopsy channel showed shavings.The investigation is still ongoing.A supplemental report will be submitted upon receiving additional information.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacture's (lm) review of the customer completed cleaning disinfection and sterilization (cds) checklist and the lms final investigation.The lm reviewed the customer provided the cds processes where information to judge deviation from the instructions for use (ifu) was not identified.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, a root cause for both the positive culture nor the burnt distal end could 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 the instructions for use (ifu) before repair, the results conformed to the regulation's recommendation.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." the user is able to detect the event of burnt distal end by following ifu as follows: operation manual_ preparation and inspection_ inspection of the endoscope "inspect the external surface of the entire insertion section, including the bending section and the distal end for dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities." 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: 18603255
• MDR Text Key: 334064792
• Report Number: 9610595-2024-01914
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170434983
• UDI-Public: 04953170434983
• 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,Health Professional,User Facility
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/01/2024

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: 01/14/2024
• Initial Date FDA Received: 01/29/2024
• Supplement Dates Manufacturer Received: 01/31/2024; 02/21/2024; 03/01/2024
• Supplement Dates FDA Received: 02/05/2024; 02/22/2024; 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2017
• 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-0194-2024
• Patient Sequence Number: 1