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

Model Number CLV-190

Device Problem Complete Loss of Power (4015)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The repair center was not able to confirm the customer's complaint.The unit was tested with 180 and 190 model scopes and displayed images without noise nor distortion.The repair center did find device damaged which was not related to the reportable malfunction.The device was repaired and returned to the customer.This mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes.A capa has been opened to manage the actions related to remediation of this issue and any required mdr reporting.

Event Description

The customer contacted olympus to report the whole machine turns off when the light is on for 30 seconds.This device malfunction was found during preparation for use.There was no patient involvement reported.

Manufacturer Narrative

This supplemental report is submitted to provide additional event related information.Updates to sections b5, e2 and e3.

Event Description

The intended procedure was completed without delay using a different device (model/serial number unknown).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, and since the event was not reproduced by the repair department, it is likely the short-circuited was caused by dust and moisture.The overcurrent protection of the power supply unit was activated and the power supply was turned off.The following descriptions are given in the instruction manual for the device not to be used in dusty environments: "avoid using the light source in a dusty environment.This may damage the light source.".

• 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: 11030232
• MDR Text Key: 225928627
• Report Number: 8010047-2020-10589
• 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,Followup
• Report Date: 01/19/2021

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: 06/01/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 12/22/2020; 01/15/2021
• Supplement Dates FDA Received: 12/23/2020; 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1