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

Model Number CLV-190

Device Problem Naturally Worn (2988)

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

Event Date 07/15/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing; therefore, the root cause of the reported malfunction cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.

Event Description

The technical support engineer was informed by the user facility that the evis exera iii xenon light source reportedly had lamp error e103 and white balance incomplete error e311 and error e931 during preparation for use.No patient involvement or harm was reported.During troubleshoot the user facility stated that the lamp life meter of the light source was at 500 hours maximum and the user facility could not white balance due to the lamp was burnt out and the spare lamp was on.The facility will change the lamp and no device will be returned.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the legal manufacturer.The legal manufacturer performed a review of the device history records for the concerned device and no abnormalities were found.The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.The concerned device was not returned for service/repair or to the legal manufacturer for evaluation, therefore the exact cause of the reported malfunctions could not be conclusively determined.The potential cause of the e103 error (clv lamp failed to light) and the spare lamp turned on malfunction occurred because the lamp exceeded the maximum lighting time due to the end of its service life.Olympus will continue to monitor complaints for 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: 12284664
• MDR Text Key: 265400592
• Report Number: 8010047-2021-09847
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/15/2021

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/15/2021
• Initial Date FDA Received: 08/05/2021
• Supplement Dates Manufacturer Received: 09/08/2021
• Supplement Dates FDA Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1