MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA III XENON LIGHT SOURCE

Model Number CLV-190

Device Problem Installation-Related Problem (2965)

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

Event Date 10/20/2022

Event Type  malfunction  

Event Description

The customer reported to olympus during a unknown procedure, air flow problem and low insufflation on the evis exera iii xenon light source.Upon inspection and testing of the returned unit, the heat compound was applied so excessive.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.A similar device was used to complete the procedure.It was moved to a different room.There was a 15-minute delay reported.There were no reports of patient harm associated with this event.

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer¿s allegation was not confirmed.The evaluation uncovered a worn-out socket slider switch cause intermittent use of high intensity mode, non-olympus lamp life meter is reading at 100+hours, light output measured within range and there was excessive black substance apply on lamp¿s body.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.

Manufacturer Narrative

This report is being supplemented to provide additional information, based on the legal manufacturer's investigation.A review of the device history record found no deviations, that could have caused or contributed to the reported issue.It has been over 3 years, since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, a definitive root cause of the excessive black substance applied on the lamp¿s body/heat compound improperly applied to the lamp could not be identified.The event can be detected/prevented, by following the instructions for use, which state: [chapter 6.3 insertion of the lamp, instruction manual of clv-190]: do not apply, the heat compound to the glass surface.And the ceramic part of the examination lamp.If any compound gets on the glass surface, wipe it off with a clean, lint-free cloth.Otherwise, the examination lamp may be damaged.And it may cause malfunction of the light source.Apply enough heat compound.If not enough heat compound is applied, the heat can cause lamp ignition failures.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15827308
• MDR Text Key: 307508322
• Report Number: 3002808148-2022-04361
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/24/2023

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: 10/24/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2022
• Initial Date FDA Received: 11/18/2022
• Supplement Dates Manufacturer Received: 02/01/2023
• Supplement Dates FDA Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2020
• 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