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

Model Number CLV-190

Device Problem Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

During an unspecified procedure, the subject device was used.It was reported that electric spark from the subject device occurred.There was no patient injury reported.No further information was provided.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.According to the information from the user, the user continued to use the subject device for a while and electric spark could be reproduced once when the endoscope, which was not completely dry was connected after this event.And, it was informed that electric spark occurred from the ventilation grill on the right side of the subject device.Also according to the evaluation result by an olympus local service engineer, it was found there were not any traces of chemical, water, or dust on the output socket of the subject device.The device history record was reviewed and found no irregularities.Based on the evaluation result so far, it was surmised that electric spark occurred around the igniter unit for lamp in the subject device, but the exact cause of the reported failure phenomenon could not be conclusively determined.The clv-190 instruction manual states the corresponding method when there is an abnormality for the device.

• 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: 9657045
• MDR Text Key: 221215261
• Report Number: 8010047-2020-01059
• Device Sequence Number: 1
• Product Code: NWB
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/18/2020

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/23/2020
• Initial Date FDA Received: 02/02/2020
• Supplement Dates Manufacturer Received: 03/05/2020
• Supplement Dates FDA Received: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1