MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA ELITE XENON LIGHT SOURCE

Model Number CLV-S190

Device Problem Defective Device (2588)

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

Event Date 07/16/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device has not returned to olympus medical systems corp.(omsc) for evaluation.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

During the preparation for an unspecified procedure using the subject device, the front panel display of the subject device blinked.Other detailed information was not provided.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) could not investigate the device, because the device was not returned to omsc.Omsc reviewed the manufacturing history (dhr) of the device and confirmed no irregularity.Since the device was not returned, the exact cause was unknown; however, the following was supposed to be the cause.- the power supply unit of the device was broken by some cause.- the light guide connection detection function was failed by some cause.The instruction manual of the subject device states the corresponding method in case of an abnormality.

• Brand Name: VISERA ELITE 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: 10377197
• MDR Text Key: 202080534
• Report Number: 8010047-2020-05360
• 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,user facility
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

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: No Information
• Device Model Number: CLV-S190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/19/2020
• Initial Date FDA Received: 08/06/2020
• Supplement Dates Manufacturer Received: 09/29/2020
• Supplement Dates FDA Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1