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

Model Number CLV-190

Device Problems Moisture Damage (1405); Failure to Power Up (1476)

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

Event Type  malfunction  

Manufacturer Narrative

The device is planned to be returned to olympus europa (b)(4) but has not been returned yet.According to information provided by a field service engineer at olympus europa (b)(4) the device could not be turned on and the power supply or power switch may be defective.A loaner unit was installed at the user facility.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 medical systems corp.(omsc) was informed by the user that the device did not turn on.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The device has not been returned to olympus medical systems corp.(omsc) but was returned to olympus deutschland gmbh (ode) for evaluation.Ode inspected the device and confirmed the following: -the reported phenomenon was reproduced and the device could not be turned on.-the power unit was out of order due to a defect in the power supply unit.The power supply unit needs to be replaced.-moisture reached the output socket and the light channel was broken.According to the evaluation by ode, this is a mdr reportable malfunction.-the air pump had a problem starting up under pressure and needs to be replaced.If additional information becomes available, this report will be supplemented.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.More than 6 years have passed since the device was manufactured.It is possible that the device could not be turned on because the power supply unit failed due to aging due to repeated use for a long period of time.In addition, the light channel may have failed due to moisture entering the output socket due to incorrect handling by the user or poor operating environment.The instruction manual provides precautions regarding the usage environment of the device, which may have prevented the light channel from failing.Device history record (dhr) review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.If additional information becomes available, this report will be supplemented.

• 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: 12047171
• MDR Text Key: 270513005
• Report Number: 8010047-2021-07866
• Device Sequence Number: 1
• Product Code: NWB
• 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,Followup
• Report Date: 08/02/2021

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: No Information
• Device Model Number: CLV-190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/01/2021
• Initial Date FDA Received: 06/23/2021
• Supplement Dates Manufacturer Received: 06/07/2021; 07/15/2021
• Supplement Dates FDA Received: 06/29/2021; 08/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1