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

Model Number CLV-180

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 08/12/2022

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated by olympus.The evaluation found that the fuse in the inlet, the lamp shaft and the front post inside the lamp chamber were burnt.The reported problem of a burnt connector on the rear of the device was not confirmed.Additional evaluation findings are as follows: bottom chassis rusted, top cover rusted, front panel chassis rusted, front panel mouth damaged and lamp door rusted.A worn scope socket was identified.Air pump flow rate was measured out of range.A non-olympus lamp with life meter at more than 200 hours was noted.The investigation is ongoing and the definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

A user facility returned the olympus, model clv-180, evis exera ii xenon light source to olympus for repair due to a report of "poor balance," image brightness problem and a "burnt" connector on the rear of the device.The problems, as reported to olympus, were identified during preparation for use.There was no patient injury, associated with the problems, reported to olympus.Upon inspection and testing of the returned device, it was determined that the fuse in the inlet, the lamp shaft and the front post inside the lamp chamber were burnt.This report is submitted due to the findings of a burnt fuse inlet, lamp shaft and front post inside the lamp chamber, all identified during in-house service of the device.As the problems were identified during in-house service of the device, there was no patient involvement.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see the updates in sections h6 and h10.Since the device is more than 15 years old, the device history record was unable to be reviewed.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely due to a faulty switching regulator.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II 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 Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15386772
• MDR Text Key: 299547910
• Report Number: 3002808148-2022-01846
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170215544
• UDI-Public: 04953170215544
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 11/01/2022

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-180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/12/2022
• Initial Date FDA Received: 09/08/2022
• Supplement Dates Manufacturer Received: 10/06/2022
• Supplement Dates FDA Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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