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

Model Number CLV-190

Device Problem Activation Problem (4042)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2020

Event Type  malfunction  

Manufacturer Narrative

The nurse further reported that multiple scopes were switched out but with the same result.There was a twenty minute delay.The intended procedure was not completed and the procedure has not been rescheduled.The light source was not returned to the service center for evaluation.The cause of the reported event cannot be determined at this time as the investigation is ongoing.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

The nurse at the user facility reported that during the middle of a diagnostic colonoscopy procedure, the evis exera iii light source produced a b30 error message.There was no patient injury reported.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the original equipment manufacturer (oem) for mdr.The oem performed a device history record review and no abnormalities were found.An investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.Based on the investigation, the oem determined that the reported b30 error occurred when the scope connectors were used without adequate drying, or when foreign objects such as dust or the remainder of the chemical solution were attached to the electrical contact point of the scope connectors.As stated on the ifu (instruction for use) and as a preventive measure, the user manual states: if the light source is soiled, perform the following cleaning procedure immediately after use.If cleaning is delayed, residual organic debris will begin to solidify, and it may be difficult to effectively clean the light source.The light source should also be cleaned routinely.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: 10224011
• MDR Text Key: 212268090
• Report Number: 8010047-2020-03832
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/15/2020

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: 06/04/2020
• Initial Date FDA Received: 07/02/2020
• Supplement Dates Manufacturer Received: 11/16/2020
• Supplement Dates FDA Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 91 YR
• Patient Weight: 59