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

Model Number	ENF-T3
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was evaluated by olympus.The evaluation found that the allegation was confirmed.Additional issues were identified during the device evaluation: the connecting tube was discolored, and due to the damage to the image guide bundle, the image had a stain.The investigation is ongoing, and follow-up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The olympus representative reported that the rhino-laryngofiberscope device displayed peeling at the bending section and insertion tube.The scope device was reported to be inspected.There were no reports of patient harm associated with this event.During the evaluation of the device, it was noted that the resin part of the image guide tube coil had fallen off.This report is to capture the reportable malfunction of the part of the connecting tube that had fallen off, as noted at estimation.
Event or Problem Description
Additional information received identified the reported phenomenon occurred during reprocessing.The unknown procedure was completed with device replacement.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Since the device is more than 15 years old, the device history record was unable to be reviewed.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the root cause of the event was unable to be identified; however, the event most likely occurred due to stress, handling, or other factors.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the customer (see updated sections b5).
Event or Problem Description
Additional information provided by the customer: the issue was found during reprocessing and the intended procedure was performed with a similar device replacement.

• 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: 16216355
• Report Number: 3002808148-2023-00636
• Device Sequence Number: 12606973
• Product Code: EOB
• UDI-Device Identifier: 04953170307188
• UDI-Public: 04953170307188
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2023

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: ENF-T3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2022
• Supplement Date Received by Manufacturer: 01/30/2023; 02/17/2023
• Initial Report FDA Received Date: 01/20/2023
• Supplement Report FDA Received Date: 02/20/2023; 03/02/2023
• 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