MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. RHINO-LARYNGO VIDEOSCOPE

Model Number ENF-VT2

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus inspected the device at the service department of olympus (b)(4) (osh) found that the instrument channel port of the device was broken.This is a spare device, which was loaned to the hospital for trial use.Olympus representative confirmed that this event didn't occur during the use of the hospital.There was no report of patient injury associated with this event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Based upon the information from olympus trading (shanghai) limited (osh) there was the possibility that the reported phenomenon was attributed to the following occurrence mechanism.- the metal part of the endo-therapy accessory or the cleaning brush interfered with the instrument channel port when the endo-therapy accessory or the cleaning brush was inserted or removed, and the reported event occurred.

• 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
• MDR Report Key: 10909929
• MDR Text Key: 227214710
• Report Number: 8010047-2020-09491
• Device Sequence Number: 1
• Product Code: EOB
• Combination Product (y/n): N
• PMA/PMN Number: K061313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ENF-VT2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1