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

Model Number CLV-190

Device Problems No Display/Image (1183); Application Program Problem (2880)

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

Event Date 05/19/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the evaluation, the user's report could not be confirmed.The unit was burned for 3 hours with the test cv-190 video processor and with several tests scopes.The video image was functioning as expected and did not enter 'standby' mode.However, a worn out scope socket slider switch was noted and causing intermittent user of high intensity mode.A non-olympus lamp meter read at 100+ hours (light output within specifications).If additional information becomes available following device evaluation, a supplemental report will be filed.

Event Description

It was reported, the evis exera ii xenon light source was entering into 'standby' mode on its own during a case.When the device goes into standby mode, the image was lost.There was no patient harm or consequence reported as a result of this event.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the manufacturer¿s investigation.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 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: ¿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.Do not apply excessive force to the light source and/or other instruments connected.Otherwise, damage and/or malfunction can occur.¿ based on the condition of the device and the results of the investigation, the reported event was caused by using a non-olympus lamp and applying excessive force to the device.During the evaluation, wear of the slider switch was confirmed.Consequently, because the movement of the slider switch became unstable, the symptom that does not become high brightness mode was expressed as entering the standby mode.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: 11958359
• MDR Text Key: 276170938
• Report Number: 8010047-2021-07242
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/13/2021

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: 05/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/19/2021
• Initial Date FDA Received: 06/08/2021
• Supplement Dates Manufacturer Received: 07/07/2021
• Supplement Dates FDA Received: 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1