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

Model Number CLV-190

Device Problem Activation Problem (4042)

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

Event Type  malfunction  

Manufacturer Narrative

The device has not yet been returned for evaluation.If additional information becomes available following device evaluation, a supplemental report will be filed.

Event Description

The customer reported to olympus that during a procedure, the device transitioned to a spare lamp.It is unknown the intended procedure was completed.There was no patient injury reported.

Manufacturer Narrative

The device has been returned and an evaluation performed for it.This supplemental report is being submitted to provide this information.Please see the updates in sections: d10, g4, g7, h2, h3, h4, h6, and h10.The device history record review confirmed that device has no abnormalities, special adoption, or variations in manufacturing.The reported issue is that during a procedure, the device transitioned to a spare lamp.This device is designed to automatically switch to emergency lights when the sighting lamp does not turn on or turns off.Upon inspection and testing, it was observed that the device lamp goes to the spare lamp.This is attributed to the faulty power supply.In addition was found: loose scope socket tab was not protecting socket pins.Device is equipped with new type switch, olympus lamp less than 50 hours, light output within specifications, housing in normal condition.The instructions for use includes the following statements (amongst others) for pre-use inspection and usage: check the lamp usage time.Check the illumination light.Turning on the power to turn on the lighting lamp.Turn off the illumination lamp.

• 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: 10036146
• MDR Text Key: 222130693
• Report Number: 8010047-2020-02549
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/13/2020
• Initial Date FDA Received: 05/07/2020
• Supplement Dates Manufacturer Received: 11/06/2020
• Supplement Dates FDA Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1