MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. RHINO-LARYNGOFIBERSCOPE

Model Number	ENF-T3
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the rhino-laryngofiberscope was sterilized, but was overloaded with bacteria.The issue was found when preparing the device for use in a diagnostic cannuloscopy procedure.Another device was used to complete the procedure.There was no reported patient harm or impact due to this event.
Additional Manufacturer Narrative
This event is under investigation.A supplemental report will be submitted upon receiving additional information.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacture's (lm) review of the customer cleaning disinfection and sterilization (cds) processes, the device evaluation and the legal manufacture¿s final investigation.Despite good faith attempts the user culture results were not shared.The lm reviewed the customer provided the cds processes where no obvious deviations from instructions for use (ifu) were identified.Based on the results of the investigation and because the user culture results were not shared, the reported event could not be confirmed, and a root cause could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: 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: RHINO-LARYNGOFIBERSCOPE
• Common Device Name: RHINO-LARYNGOFIBERSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19174174
• Report Number: 3002808148-2024-03823
• Device Sequence Number: 7456301
• Product Code: EOB
• UDI-Device Identifier: 04953170307188
• UDI-Public: 04953170307188
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K011869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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
• Operator of Device: Health Professional
• Device Model Number: ENF-T3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2024
• 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: 04/09/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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