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

Model Number CLV-S190

Device Problems Break (1069); Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 01/22/2021

Event Type  malfunction  

Manufacturer Narrative

The unit was returned to the service center for evaluation.The customer¿s complaint of ¿popping noise ; burning smell and that was giving e-103" was confirmed due to shattered lamp.¿ in addition, the scope socket was found worn out causing a poor connection.The unit was equipped with an old version switch.Normal wear was noted on the unit¿s housing.The investigation of this event is ongoing and if additional information is received this report will be supplemented accordingly.

Event Description

The service center was informed that the light source made an audible popping noise , prompted an ¿e103¿ lamp light up error code and gave a burnt smell.There was no patient involvement reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Multiple documented attempts to obtain additional information from the user facility have been unsuccessful, to-date.Based on the results of the investigation, the lamp likely shattered due to a scratch on the lamp, which led to the popping sound, the burnt smell, and the e103 error (clv lamp failed to light).A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.

• 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: 11342276
• MDR Text Key: 232334402
• Report Number: 8010047-2021-02832
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170301995
• UDI-Public: 04953170301995
• Combination Product (y/n): N
• PMA/PMN Number: EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/17/2021

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-S190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/18/2021
• Supplement Dates Manufacturer Received: 03/16/2021
• Supplement Dates FDA Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1