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

Model Number ENF-VQ

Device Problem Material Separation (1562)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, as noted in b5, the resin part of the insertion guide coil fell off of the device.Additionally, the bending angle was found to be insufficient.The insertion tube had collapsed and had discoloration present.The universal cord was crushed.The light guide bundle was broken, and the unit had scratching present throughout.If additional information becomes available following the device evaluation, a supplemental report will be filed.

Event Description

The customer originally returned his olympus rhino-laryngo videoscope due to the bending section and insertion tube having coating defects present.Additional details relating to the patient and the event have been requested but the initial reporter did not have any answers to provide.There was no patient harm or consequence reported as a result of this event.During the device evaluation, it was discovered that the resin portion of the insertion guide coil had fallen off.This report is being submitted to capture the component separation found during the device evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation and correction to h4.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 resin portion of the insertion guide coil detachment was caused by chemical stress or physical stress.Olympus will continue to monitor field performance for this device.

• Brand Name: RHINO-LARYNGO VIDEOSCOPE
• Type of Device: RHINO-LARYNGO VIDEOSCOPE
• 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: 17003098
• MDR Text Key: 316511119
• Report Number: 3002808148-2023-05289
• Device Sequence Number: 1
• Product Code: EOB
• UDI-Device Identifier: 04953170291050
• UDI-Public: 04953170291050
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K061313
• 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: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENF-VQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2010
• 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