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

Model Number LF-TP

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2022

Event Type  malfunction  

Event Description

The end user facility contacted olympus to report a repair request for air and/or water leakage issues with a tracheal intubation fiberscope.During preliminary evaluation and inspection of the returned subject device, a rubber was found to be falling off.This mdr is being submitted due to the detached rubber found during evaluation and inspection.No patient or user harm has been reported.

Manufacturer Narrative

The subject device has been returned to an olympus repair center for preliminary evaluation and inspection, and the customer's reported problem has been confirmed.The detached rubber was also confirmed.Wrinkles, dents, scratches, and cuts were also found throughout the device.This investigation is ongoing and additional information has been requested regarding this event.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final 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 25 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.

Event Description

There was no patient involvement with the reported issue.The procedure name is unknown, but the procedure had been completed with the same device.The reported issue was found during reprocessing, after use.

• Brand Name: TRACHEAL INTUBATION FIBERSCOPE
• Type of Device: 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16100031
• MDR Text Key: 308713886
• Report Number: 9610595-2023-00182
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170136825
• UDI-Public: 04953170136825
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K981543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/10/2023

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
• Device Operator: Other
• Device Model Number: LF-TP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2022
• Initial Date FDA Received: 01/04/2023
• Supplement Dates Manufacturer Received: 01/11/2023
• Supplement Dates FDA Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/1998
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1