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

Model Number LF-TP

Device Problem Peeled/Delaminated (1454)

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

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was observed during the device inspection, that the fiberscope exhibited the coating of the image guide hose peeled off 1 to 2mm or more.There were no reports of patient involvement.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Correction to h6 component code: 3072 - hose does not apply to this event.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 5 years since the subject device was manufactured.Based on the results of the investigation, the peeled coating was likely caused by stress of repeated use, external factors or handling; however, a definitive root cause could not be determined.The event can be detected by following the instructions for use: ¿chapter 3 preparation and inspection 3.2 preparation and inspection of the endoscope".Olympus will continue to monitor field performance for this device.

• 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: 19201519
• MDR Text Key: 341572822
• Report Number: 9610595-2024-08828
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/28/2024

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
• Device Operator: Other
• Device Model Number: LF-TP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/23/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: 05/20/2024
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2018
• 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