MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. RHINO-LARYNGO FIBERSCOPE; RHINO-LARYNGOFIBERSCOPE

Model Number ENF-GP2

Device Problems Crack (1135); Poor Quality Image (1408)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It is reported that a rhino-laryngo fiberscope had an unclear picture, and a small piece missing from near the tip.There was no patient impact related to this occurrence.

Manufacturer Narrative

The device referenced in this report has been received by olympus for physical evaluation.The user report was confirmed.The scope failed the fog test due to a sunken objective lens.This phenomenon is attributed to mishandling.The investigation is ongoing.The definitive cause of the customer's experience can not yet be determined.This report will updated upon completion of the investigation or upon receipt of additional relevant information.

Manufacturer Narrative

This report is being updated to report additional information provided by the customer.

Event Description

Additional information provided by the customer 03dec2020: it was during the beginning of a nasopharyngoscopy laryngoscopy procedure when the image became blurry.There was a 10 minute delay in the procedure when they went to get a different scope, no general anesthesia involved.There was no patient injury involved in this event.The product information for the replacement scope and concomitant devices are unknown.At the time of the event, the doctor was just placing the scope within the nose.The user did not do a specific evaluation of the device before use, however he confirmed that the device intact and cleaned prior to use.There were no other devices involved in the event.The connections were checked and found to be secured.The lens was cleansed with an alcohol pad at time of the cloudy image.The objective lens was free of condensation.The small piece of the device that was noted to be missing from the tip did not fall into a patient.It is unknown how the piece broke off.The device did not sustain a deep impact or come in contact with a sharp corner.

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 (dhr) found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the probable cause of the reported issue (small piece missing from the tip) is likely that an external force was caught on the a rubber of the distal end, causing the tip to fall off and blurring of the image.Regarding the sunken objective lens, per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• Brand Name: RHINO-LARYNGO FIBERSCOPE
• Type of Device: RHINO-LARYNGOFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 10941424
• MDR Text Key: 227497944
• Report Number: 8010047-2020-09787
• Device Sequence Number: 1
• Product Code: EOB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENF-GP2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2019
• 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