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

Model Number CLV-260SL

Device Problems Gas Output Problem (1266); No Flow (2991)

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

Event Date 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

The subject clv-260sl does not return to olympus.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

During the unspecified procedure with the clv-260sl, the air feeding of the subject clv-260sl through the unspecified endoscope could not be operated.The user replaced the subject clv-260sl to an unspecified similar system and completed the procedure using the same endoscope.There was no report of the patient¿s injury regarding this event.The local service engineer reported the following evaluation result of the subject clv-260sl.The excessive dust collected inside the subject clv-260sl.The air pump incorporated in the subject clv-260sl was faulty.The phenomenon that the user mentioned was reproduced.

Manufacturer Narrative

This is a supplemental report for mfr report #8010047-2018-02569.The subject clv-260sl was not returned to olympus medical systems corp.(omsc).The root cause of this event could not be conclusively determined, because omsc could not investigate the subject clv-260sl.Omsc checked the device history record of the subject device, and there was no irregularity found.As ten years or more has passed since the manufacture date of the subject clv-260sl, omsc surmised that the air pump incorporated in the subject device was faulty by aging degradation or other.The instruction manual of the clv-260sl states the corresponding method in case of an abnormality.

Manufacturer Narrative

This supplemental report is submitting to correct "device product code".

• Brand Name: EVIS LUCERA XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8198414
• MDR Text Key: 131722821
• Report Number: 8010047-2018-02569
• Device Sequence Number: 1
• Product Code: GCT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CLV-260SL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1