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

Model Number CLV-190

Device Problems Display or Visual Feedback Problem (1184); Device Emits Odor (1425); Temperature Problem (3022)

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

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

The suspect device was returned to olympus and evaluated.The reported problem was confirmed.The unit displayed the e102 error after 10 minutes of operating.It was noted that debris and dust were accumulated inside the device.In addition, insufficient thermal paste was present on the lamp, causing it to overheat.Replacement of the lamp and removal of the debris was required in order to resolve the issue.In addition, the b30 error was generated intermittently; replacement of the scope socket and support coil was required due to a faulty scope socket.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.This mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes.An investigation has been opened to manage the actions related to remediation of this issue and any required mdr reporting.

Event Description

A user facility reported to olympus that the unit switched over to the spare lamp, an error e102 (light source temperature switch error) was generated and a burning smell was detected.The problem, as reported to olympus, occurred during a procedure.There was no patient injury or harm, associated with the problem, reported to olympus.

Event Description

The reported problem occurred during the middle of a diagnostic colonoscopy procedure.There was no delay in the procedure in which the device was used.The procedure was completed using the same device.The endoscope was removed using the spare lamp.There was no patient injury or medical intervention associated with the event.

Manufacturer Narrative

This supplemental report is submitted to provide additional event related information.Updates to sections b3, b5, e2 and e3.

Manufacturer Narrative

This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation.The dhr for the subject device was reviewed and it was verified the device was manufactured in accordance with documented specifications.The legal manufacturer performed an investigation.A conclusive root cause was not identified.The investigation determined the likely cause of the of the reported event was due to the main lamp reaching the end of life due to the frequency of use during the life of the device.In addition, the investigation determined that the device was likely used in a high temperature environment or with the ventilation grills obstructed, leading to overheating of the lamp.The investigation determined the faulty scope socket, found on the device evaluation, was likely due to the endoscope repeatedly attached and detached with a high frequency of use.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 11403703
• MDR Text Key: 234539254
• Report Number: 8010047-2021-03241
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/18/2022

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: 01/07/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 03/03/2021
• Supplement Dates Manufacturer Received: 03/03/2021; 03/30/2021; 01/27/2022
• Supplement Dates FDA Received: 03/03/2021; 04/14/2021; 02/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1