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

Model Number CLV-190

Device Problems Power Problem (3010); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

There is no additional information for this event as yet.Event date is not known.The device has been returned and a device evaluation completed for it.The manufacture date is not known.The user¿s complaint was confirmed.Upon inspection, it was observed that the user issues with the lamp causing the spare lamp to come on intermittently were caused by the non-olympus lamp.When tested with the test lamp the device functioned normally without any issue.The non-olympus lamp life meter is reading at 100+ hours.In addition, the main switch tended to stick and remain depressed.The scope socket had moisture stain that needed cleaning.The housing had a deep scratch on the top cover and front panel was cracked.The fan was running okay and air pressure tested okay as well.

Event Description

As reported for this event, during an unknown procedure, the device lamp would give issues with lighting every so often.The service lamp would kick on and be dim.The device needed to be powered off and on again for the main lamp to be on.There was no reported adverse impact to the patient.

Manufacturer Narrative

There is more information on the device evaluation.This supplemental report is being submitted to provide this information.Please see the updates in sections: g4, g7, h2, h4, and h10.No repair history is available for the device.The reported issue for the device was lamp issues.Likely cause of the issues are: user did not notice (or ignored) the descriptions in the instruction manual and mounted a non-desired lamp (non-specified product).Power switch was damaged because the amount of operating force and the number of times the power switch was applied exceeded the assumed value, since the product was manufactured before the countermeasure change introduced in the design of the power switch to strengthen its resistance to damage.Deterioration due to long-term use, or by corrosion and rusting as a result of the water being left on during use or cleaning, or a large load deviating from the recommended use conditions (for example, a hard object is accidentally crushed by mistake, etc.) from outside instantaneously.

• 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: 10271205
• MDR Text Key: 223243507
• Report Number: 8010047-2020-04395
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/04/2020

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-190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/19/2020
• Initial Date FDA Received: 07/14/2020
• Supplement Dates Manufacturer Received: 11/11/2020
• Supplement Dates FDA Received: 12/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1