MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. 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

This combined initial/final report is being submitted to provide the customer reported event as well as the results of the manufacturer¿s investigation.A device evaluation, a review of the device history record (dhr), a review of the instructions for use (ifu), as well as a historical trending analysis were conducted during this investigation.The subject device was returned and evaluated.During the device evaluation the bending angle was noted to be insufficient due to an elongated angle wire.The angulation control lever was not functioning smoothly.The bending tube section of the insertion tube was dented.The universal cord, video cable, tip cover, light guide connector, video connector, video cable, and control panel all had scratches present.The manufacturing label of the light guide connector was peeling.The boot on the side of the scope connector of the universal cord had cuts present.Due to abrasion on the object lens, flares were found in the image.The unit was also experiencing an air leakage from the detached distal end.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The ifu contains the following statements: ¿inspect the covering of the bending section for sagging, swelling, cuts, holes, or other irregularities.¿ based on the results of the device evaluation as well as the investigation findings, a definitive root cause for the reported event could not be confirmed.Olympus will continue to monitor the field performance of this device.

Event Description

The customer originally returned their olympus rhino-laryngo videoscope due to an air/water leakage noted at the insertion tubing.The initial reporter was unable to confirm where this issue was found during procedure preparation or during the procedure itself.The customer did note that the case was likely a diagnostic one as the event occurred in the otolaryngology outpatient department.Reportedly, no patient was experienced as a result of this event.During the device evaluation, it was discovered that part of the bending section had separated.This report is being submitted to capture the material separation noted during the device evaluation.

• Brand Name: RHINO-LARYNGO VIDEOSCOPE
• Type of Device: RHINO-LARYNGO VIDEOSCOPE
• 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: 14250660
• MDR Text Key: 290453760
• Report Number: 8010047-2022-07311
• 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
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• 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: 04/04/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2010
• 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