MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES BRONCHOFIBERSCOPE

Model Number	BF-1T60
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The olympus scope was sent to an independent laboratory for culture testing.Cultures were taken from the distal end and the washings from the suction channel.One colony forming unit (cfu) of acinetobacter radioresistens was identified from the suction channel washings.The obtained results are in conformance with the requirements.After the device undergoes a second reprocessing cycle, additional culture sampling will be performed and the device will be evaluated.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
The customer reported to olympus, the oes bronchofiberscope tested positive for a microbial contamination.The issue was found during routine culturing of the scope.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.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.The device was evaluated where no abnormalities were found that could have led to the positive culture.Multiple defects were noted during the evaluation including the bending section rubber was leaking, the insertion section was kinked and wrinkled, the universal cord was kinked, the diopter ring was discolored, the image guide fiber had a breakage, and replacement of all channels and cylinders was required due to normal wear and tear over time.However, these defects are 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.It has been 12 years and 11 months since the subject device was manufactured.Based on the results of the investigation, it is unlikely the positive culture was caused by the device.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 following is included in the instructions for use (ifu): "precautions: failure to properly clean and high-level disinfect or sterilize endoscopic equipment after each procedure can compromise patient safety.To minimize the risk of transmitting diseases from one patient to another, after each procedure the endoscope and the equipment must undergo thorough manual cleaning followed by high-level disinfection or sterilization, follow the description in ¿cleaning, disinfection and sterilization procedures¿." "reprocess not only the external surface of the endoscope but also all of the channels.".
Event or Problem Description
Additional information was provided from the customer.The customer declined to repair the device and has decided to purchase a new scope and requested free disposal.
Additional Manufacturer Narrative
This supplemental report is submitted to provide additional information obtained from the customer.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.

• Brand Name: OES BRONCHOFIBERSCOPE
• Common Device Name: BRONCHOFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12843718
• Report Number: 8010047-2021-14827
• Device Sequence Number: 4232323
• Product Code: EOQ
• UDI-Device Identifier: 04953170339264
• UDI-Public: 04953170339264
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K023984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2022

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
• Operator of Device: Health Professional
• Device Model Number: BF-1T60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2021
• Supplement Date Received by Manufacturer: 12/14/2021; 01/17/2022
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 01/13/2022; 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown