MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. OES BRONCHOFIBERSCOPE

Model Number BF-P60

Device Problem Microbial Contamination of Device (2303)

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

Event Date 11/07/2023

Event Type  malfunction  

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 and results are still pending.The cleaning, disinfection, and sterilization (cds) was performed by the customer.The customer did not provide the specific steps taken during the cleaning sterilization and disinfection (cds) process.Sampling was conducted after storage in a plasma typhoon.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 device was quarantined after positive culture was observed.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 that during routine microbiological testing, the oes bronchofiberscope tested positive for >100 colony forming units (cfus) of staphylococcus capitis and staphylococcus epidermidis in the operating channel and >100 cfu of staphylococcus epidermidis and moraxella in the insufflation channel.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

Updated fields: h3, h4, h6, h10.Corrected fields: b3, d8 (inadvertently missed), d9 (device was returned prior to initial submittal).This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Olympus provided the following result of the culture test, performed at the third-party labs: sampling date: nov 29, 2023.Sampling from: all channels.Colony forming unit (cfu): <1 cfu.Bacterial identification: no bacteria detected.The device was evaluated and no abnormalities were found that could have led to the positive culture.The following defect was noted during the evaluation: broken fiber on the image guide bundle.This defect alone is not considered severe enough to cause a potential adverse event.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 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 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."   olympus will continue to monitor field performance for this device.

• Brand Name: OES BRONCHOFIBERSCOPE
• Type of Device: BRONCHOFIBERSCOPE
• 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: 18251728
• MDR Text Key: 330127018
• Report Number: 9610595-2023-18577
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170339196
• UDI-Public: 04953170339196
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K023984
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/27/2023

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-P60
• 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: 11/13/2023
• Initial Date FDA Received: 12/01/2023
• Supplement Dates Manufacturer Received: 12/20/2023
• Supplement Dates FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2018
• 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