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

Model Number CLV-190

Device Problems Degraded (1153); Physical Resistance/Sticking (4012)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and repair.The evaluation confirmed the user report.The unit is missing the switch harness and is unable to turn on.The switch is also an old version.The evaluation also found a worn out scope socket switch causing intermittent high intensity mode and a non-olympus lamp with 300+ hours and output within specifications.This event is under investigation.A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported the power switch of the evis exera iii xenon light source was stuck in and would not retract out.It was reported there was no patient death, injury, or infection due to this occurrence.It is unknown if there was patient involvement in this event.

Manufacturer Narrative

The supplemental report is submitted to provide the additional result of the legal manufacturer¿s investigation.Per investigation, the device was missing the switch harness following a third-party repair for customer.The device is unable to power on without the switch harness.Olympus will continue to monitor the field performance of this device.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the manufacturer's investigation.As part of the investigation, a review of the device history record (dhr) and a review of the instructions for use (ifu) were conducted.The dhr review did not find any abnormalities or anomalies identified during production.The device met specifications upon release.The root cause of the power switch damage was determined to be repeated use of the old switch type over time.An updated power switch design has since been released.The root cause of the socket slider switch wear was also attributed to repeated use over a long period of time.The root cause of light level below the standard output was determined to be failure to use a non-olympus lamp and a lamp life of over 300 hours.The ifu contains the following statements regarding the lamp that may prevent the experienced lamp issues: -"never install a lamp that has not been approved by olympus.The use of a nonapproved lamp can cause damage to the light source and ancillary equipment, malfunction or a fire." olympus will continue to monitor the field performance of this device.

• 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: 11592637
• MDR Text Key: 245928515
• Report Number: 8010047-2021-04367
• 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: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2021

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: 03/04/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/06/2021
• Initial Date FDA Received: 03/30/2021
• Supplement Dates Manufacturer Received: 04/05/2021; 05/12/2021
• Supplement Dates FDA Received: 04/22/2021; 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1