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

Model Number CLV-S190

Device Problem Connection Problem (2900)

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

Event Date 04/22/2020

Event Type  malfunction  

Manufacturer Narrative

Device has been returned for evaluation.The customer¿s complaint of image processor issue was confirmed.The service technician found a damaged scope connector stuck in the scope socket making it difficult to plug in new scope connector.In addition, old version main switch was broken, required upgrade to new version main switch.Heavy corrosion on the chassis, front panel chassis, top cover, and rear panel was observed.The bottom and rear feet were missing.A non-olympus lamp was over 500 hours, light output out of specifications.Unit equipped with new lamp, switch, feet, chassis, front panel chassis, scope socket, rear panel, and top cover.The device passed all functional tests and specifications.The cause was traced to a component failure.No further information was reported.

Event Description

The customer reported to olympus that the image processor or light source's white balance/on off button was not functioning.There was no patient injury reported.

Event Description

The failure occurred during setup.There was no delay, injury or medical intervention associated with this event.The power button was sticking.The device was able to be powered on and off.There was no physical damage noted on the device.All the connections were inspected and found to be secured.

Manufacturer Narrative

This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation and device history record (dhr) review.The dhr was reviewed for the subject device.No anomalies were noted and it was verified the device was manufactured in accordance with documented specifications and procedures.The legal manufacturer performed an investigation.A conclusive root cause was not identified.The legal manufacturer determined the likely causes as follows: 1.) it was confirmed that the on/off button did not work.The old version of the main switch was broken, so it was necessary to upgrade the switch to a new version.2.) wear and tear of the socket of the clv-s190 according to following: it was confirmed that the white balance did not work because of broken scope connector of the scope due to a worn out socket slider switch, causing intermittent use of the high luminosity mode.

• 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: 10084162
• MDR Text Key: 222141108
• Report Number: 8010047-2020-02873
• 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: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2020

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-S190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/01/2020
• Initial Date FDA Received: 05/22/2020
• Supplement Dates Manufacturer Received: 05/22/2020; 10/02/2020
• Supplement Dates FDA Received: 05/28/2020; 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1