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

Model Number CLV-190

Device Problems Unintended Power Up (1162); Optical Problem (3001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The repair center was unable to reproduce the complaint.Although it has not been reproduced by the repair department, it is assumed that 5 years or more have passed since the manufacture of the device in question, and that the led on the front panel blinked due to one of the following errors caused by a temporary malfunction: border position adjustment failed; rgb, light-shielding filter abnormal; turret error; wright guide error.As the results of the dhr review, it was confirmed that there was no abnormality in manufacturing, concession, and variation.

Event Description

The customer contacted olympus to report, that during a procedure, the light source started flickering and the air pump turned on.There was no report of consequence or impact to the patient.

Event Description

Updates on reported event: during the event, a scope was also used but there were no issues with the scope (product information on scope not provided).The procedure was completed with the same device.No other devices were replaced during the procedure.There was no procedural delay.There was no patient injury or medical intervention associated with this event.There is no additional information available regarding this event.

Manufacturer Narrative

This supplemental report is being submitted to provide the customer response and updates.

• 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: 10978023
• MDR Text Key: 227200685
• Report Number: 8010047-2020-10118
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

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-190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 12/09/2020
• Supplement Dates Manufacturer Received: 12/07/2020
• Supplement Dates FDA Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1