MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. TRACHEAL INTUBATION FIBERSCOPE

Model Number	LF-GP
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
No additional information provided.
Additional Manufacturer Narrative
Corrected data: h3, h11.This supplemental report is being submitted to provide the legal manufacturer¿s final investigation.It has been over 1 year since the subject device was manufactured.The device was returned to olympus for inspection.Based on the results of the investigation, a definitive root cause could not be established.It is likely the following led to the malfunction: probable causes due to some kind of stress such as damage or deterioration of parts, electrical problem, environmental temperature problem, and maintenance problem.The most probable cause of this complaint is expected or random component failure without any design or manufacturing issue.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
Complaint allegation was confirmed as documented in as-investigation codes.Investigation supported by ptis.Reference coding table on allegations and investigation conclusions.No further escalation required.The subject device will not be returned to ric from rrc.The investigation results are summarized in "product analysis".This complaint investigation is supported by previous investigations conducted through the product technical investigation (pti) process.As investigation.Rrc.Ric.
Event or Problem Description
It was observed during the device inspection that the fiberscope exhibited the coating of the insertion tube had peeled off more than 1mm2.There were no reports of patient involvement.The reportable malfunction was identified by olympus.Hold for ip 03172025.

• Brand Name: TRACHEAL INTUBATION FIBERSCOPE
• Common Device Name: TRACHEAL INTUBATION FIBERSCOPE
• 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 21619983
• Report Number: 9610595-2025-03962
• Device Sequence Number: 6706069
• Product Code: EOQ
• UDI-Device Identifier: 04953170340215
• UDI-Public: 04953170340215
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K981543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2025

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: Other
• Device Model Number: LF-GP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown