MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III XENON LIGHT SOURCE

Model Number CLV-190

Device Problem Incomplete or Inadequate Connection (4037)

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

Event Type  malfunction  

Manufacturer Narrative

Additional information for this device is not yet available.Event date is not known.Supplemental report(s) will be filed as any information becomes available.The device has been returned and a device evaluation completed for it.Manufacture date is not yet available.The user¿s complaint was confirmed.Upon inspection and testing, there was a contact issue with the device connector.The user¿s complaint of the b30 error code was confirmed.Other incidental observations were power switch is faulty and hard to turn on/off the device.

Event Description

As reported for this event, during preparation for use for an unknown procedure, the b30 scope detection error was observed for the device.The displayed screen was multicolor.There is no patient involvement and no harm reported to any patient.

Manufacturer Narrative

There is more information on the device evaluation.This supplemental report is being submitted to provide this information.The device history record review confirmed that device has no abnormalities, special adoption, or variations in manufacturing.Since the device has been in use for approximately five years, it is likely that the locking and pins of the video connectors have worsened due to repeated use for a long period of time, resulting in failure.Or, the connector contact failure occurred due to the user's application of force such as forcibly connecting the scope connector, diagonally connecting, excessive bending, pulling, twisting, crushing, etc.Or, the corrosion of the connector occurred by the user having left foreign matter such as dust, dirt, or the remainder of the chemical liquid adhered to it, and the issue occurred.When dust or dirt is attached to the electric contact point, communication between the video controller and the scope cannot be performed normally, and a scope communication error (b30) occurs.It is likely that the power switch section was damaged because a large load deviating from the normal operating conditions (e.G., a hard one accidentally crushed) was momentarily applied from outside.The instructions for use includes the following statements: drying of the electric contact points is described below in the instructions for use, which can prevent the issue from happening: make sure that the video connector and its electrical contacts are completely dry before connecting the plug to the video system center.

• Brand Name: EVIS EXERA III XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11454289
• MDR Text Key: 244800233
• Report Number: 8010047-2021-03542
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 04/27/2021

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: Health Professional
• Device Model Number: CLV-190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/17/2021
• Initial Date FDA Received: 03/10/2021
• Supplement Dates Manufacturer Received: 04/06/2021
• Supplement Dates FDA Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1