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

Model Number	LF-P
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The technical assistance center (tac) emailed the customer the reprocessing manual to resolve the issue.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the event was unable to be identified.According to the investigation result, investigators were not able to specify occurrence cause of the event and the issue was resolved at the user facility.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer reported to olympus that the tracheal intubation fiberscope was incorrectly reprocessed.The customer called into the olympus technical assistant center and asked if the scope could be stored in a sleeve.There was no patient harm associated with the event.Additional information from the customer reported that the facility usually transports scopes that have been cleaned and reprocess in a sleeve, and this was the question to the olympus technical assistant center by one of the customers tjc inspectors that inspect scopes.The customer also reported that the scope was not used but needed to be reprocessed due to exceeding the 14-day hang time in a scope container/closet.

• 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: 17373507
• Report Number: 9610595-2023-10448
• Device Sequence Number: 6978209
• Product Code: EOQ
• UDI-Device Identifier: 04953170051098
• UDI-Public: 04953170051098
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K221631
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2023

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: LF-P
• Device Catalogue Number: 2882730
• Was Device Available for Evaluation?: No
• 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: 06/23/2023
• Initial Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2013
• 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