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

Model Number CLV-180

Device Problem Optical Discoloration (2999)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The subject device clv-180 was not returned to olympus medical systems corp.(omsc).Omsc analyzed the dhr of the subject clv-180, no abnormality was found.The instructions for use of the clv-180 include warnings or cautions describing how to handle the subject device when any irregularity is observed.Omsc has not been identify the cause of this malfunction.Omsc estimates that the cause of the subject event is applicable to one of the following: the optical filter inside the clv-180 did not operate properly due to aged deterioration or the like.The image processing board inside the clv-180 malfunctioned due to aged deterioration or the like.The video signal of the scope was not properly transmitted to the clv-180 due to aged deterioration or the like.

Event Description

During an unspecified procedure of endoscopic photodynamic diagnosis (pdd) using the clv-180, the color of the entire endoscope image changed.The user replaced the clv-180 with an unspecified similar device and completed the procedure.While replacing the clv-180, the procedure was interrupted for a while and the procedure prolonged.There was no report of the patient¿s injury regarding this event.

Manufacturer Narrative

This supplemental report is submitting to correct "device product code".

• 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
• MDR Report Key: 7730496
• MDR Text Key: 115651315
• Report Number: 8010047-2018-01483
• Device Sequence Number: 1
• Product Code: GCT
• Combination Product (y/n): N
• PMA/PMN Number: K072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1