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

Model Number CLV-190

Device Problems Electrical /Electronic Property Problem (1198); Output below Specifications (3004)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus on (b)(6) 2020.During device evaluation, the complaint could not be confirmed and the brightness adjustment functioned normally.The iris was found in normal condition.A non-olympus lamp with 100+ hours was found being used with the device and excessive thermal paste was applied.The light output reading was very low.The device was repaired and the customer was advised to check their light source cable connection for possible causes of the complaint.The device history record (dhr) was reviewed and did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.A review of the instructions for use (ifu) identified the following statements: "properly and securely connect all cables.If the cable connector has connection screws, tighten up the screws.Otherwise, equipment damage or malfunction can result." "never install a lamp that has not been approved by olympus.The use of a non-approved lamp can cause damage to the light source and ancillary equipment, malfunction or a fire." the root cause could not be confirmed.Possible root causes include a problem with another device other than the one in question (video processor, scope), an incorrectly connected light source cable, use of non-specified items, use of non-specified product, and deterioration of lamp over time due to prolonged use.Olympus will continue to monitor the performance of this device.

Event Description

It was reported that during a procedure, the lamp of the evis exera iii xenon light source does not lighten automatically.It was reported the dimming is intermittent and the auto mode is not working.As reported, there was no patient harm or impact due to this occurrence.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 11163935
• MDR Text Key: 233458688
• Report Number: 8010047-2021-01324
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• 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: 08/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1