MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. 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	01/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation of the returned device confirmed the customer allegation.Leakage from air valve and eyepiece unit was noted.Cementing and scratching of adhesive on the bending section cover was noted.Damage of the connecting tube and crack of the up/down lever was noted.The device will be returned to customer for disposal due to suspicion of creutzfeldt-jacob disease (cjd).The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental will be submitted on completion of investigation or if any additional information is available.
Event or Problem Description
The customer reported to olympus, leakage at the eyepiece of bronchofiberscope was noted during reprocessing.The device was returned and an evaluation at the repair center revealed, the subject device was reprocessed in the same reprocessor as the endoscope with a confirmed creutzfeldt-jacob disease (cjd) contamination.This report is being submitted to capture suspicion of cjd found during device evaluation.There were no reports of patient harm associated with the event.Patient identifier # (b)(6) captures complaint on the scope with cjd contamination (model: bf-1th190, model description:evis exera iii bronchovideoscope, serial no.(b)(4) ).
Event or Problem Description
The customer provided additional information regarding creutzfeldt-jacob disease (cjd) contamination.The customer reported that there were no indications of non-sporadic cjd and appropriate reprocessing of scopes was performed by facility after use in cjd patients.
Additional Manufacturer Narrative
This report is being submitted for additional information provided by the customer.Please see updates to: b5.The investigation is ongoing.A supplemental will be submitted on completion of investigation or if any additional information is available.
Event or Problem Description
It was further reported, the subject device is still in quarantine at the workshop.Since the processing took place in the workshop, there was no patient involvement.
Additional Manufacturer Narrative
This report is being submitted for additional information regarding the event.The investigation is ongoing.A supplemental will be submitted on completion of investigation or if any additional information is available.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 17 years since the subject device was manufactured.It was confirmed that there was no repair history in the past one year.Based on the results of the legal manufacturer's investigation, deviation from ifu (instructions for use) related to reprocessing for cjd (creutzfeldt-jacob disease) patients/contamination via user handling was not confirmed.Olympus will continue to monitor field performance for this device.

• Brand Name: OES BRONCHOFIBERSCOPE
• Common Device Name: 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: 16362480
• Report Number: 9610595-2023-02340
• Device Sequence Number: 6908552
• Product Code: EOQ
• UDI-Device Identifier: 04953170339264
• UDI-Public: 04953170339264
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K023984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/09/2023

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
• Operator of Device: Health Professional
• Device Model Number: BF-1T60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2023
• Supplement Date Received by Manufacturer: 03/10/2023; 04/21/2023; 05/17/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 03/14/2023; 04/21/2023; 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2005
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ETD REPROCESSOR.
• Patient Sex: Unknown