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

Model Number CLV-180

Device Problem Fracture (1260)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.Based on the initial evaluation, the spare lamp was found to be not working due to a damaged turret.The shield was damaged.There were dusts found inside the unit, and there were minor dents and scratches on the top cover, and front panel.Upon completion of the investigation, or if additional information should become available, a supplemental report will be submitted.

Event Description

As reported, the evis exera ii xenon light the lamp broke.According to the evaluator, the wheel of the nbi glass broke.There was no patient involvement with this event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information and to correct the "d9 device availability" in the initial report.The d9 "returned to manufacturer" selected in the initial report is incorrect because the device has not been returned to olympus medical systems corp.(omsc).The exact cause of the reported event could not be conclusively determined, because the device has not been returned to omsc.However, omsc concluded that the reported event that the evis exera ii xenon light the lamp broke may have been caused by the inability to use the device as a light source due to a turret error caused by a turret unit failure.In addition, there is possibility that the emergency lamp did not work because the turret could not be moved to the specified position due to damage to the turret unit and could not pass the illumination light of the emergency lamp.Device history record (dhr) review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.If additional information becomes available, this report will be supplemented.

• Brand Name: EVIS EXERA II 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: 11148956
• MDR Text Key: 240415907
• Report Number: 8010047-2021-01176
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170215544
• UDI-Public: 04953170215544
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

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-180
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 01/11/2021
• Supplement Dates Manufacturer Received: 02/24/2021
• Supplement Dates FDA Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1