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

Model Number CLV-190

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned to omsc for evaluation.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.However, based on the information from (b)(4) which the carried componential analysis with the external laboratory, there was the possibility that the foreign material invaded from the outside of the subject device.Omsc surmised that the reported phenomenon was attributed to the foreign materials invaded with mixed the intake from the ventilation grilles for cooling light source in under normal use.

Event Description

Olympus medical systems corp.(omsc) was informed from the facility that in unspecified timing, it was found that there were foreign materials on the 3 parts (the tube, the joint u and the support coil) of the subject device.The parts returned to olympus (b)(4).(b)(4) sent the parts to an external laboratory for the componential analysis.The results of the analysis revealed the followings.There were no findings indicating chemical deterioration of the parts (sus coil and the pvc tube).The main component of the foreign material was nickel.There was no report of patient injury associated with this event.

Manufacturer Narrative

This supplemental report is being submitted to provide the subject device evaluation result.The subject device was returned to olympus medical systems corp.(omsc) for investigation.Omsc confirmed that there were foreign materials on the 3 parts (the tube, the joint u and the support coil) of the subject device and dust on the air horse.Omsc surmised that the reported phenomenon was attributed to the foreign materials invaded with mixed the intake from the ventilation grilles for cooling light source in under normal use.

• 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: 11105196
• MDR Text Key: 224808995
• Report Number: 8010047-2021-00797
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/12/2021

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: No Information
• Device Model Number: CLV-190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 01/03/2021
• Supplement Dates Manufacturer Received: 06/22/2021
• Supplement Dates FDA Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1