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

Model Number CLV-260

Device Problem No Display/Image (1183)

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

Event Date 06/19/2018

Event Type  malfunction  

Manufacturer Narrative

The subject clv-260 has not been returned to olympus medical systems corp.(omsc) yet.Omsc will investigate the subject clv-260 to identify the root cause of this failure phenomenon when omsc receives it.The exact cause of the reported event could not be conclusively determined at this time.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

Near the end of ercp, the facility tried to place the pancreatic stent in the patient's body.At that time, the endoscopic image displayed on an unspecified monitor was disappeared.The facility continued and completed the procedure without using the endoscopic image.But, the facility could not confirm whether the pancreatic stent was definitely placed in the patient's body.There was no report of the patient's injury regarding this event.At this time, the facility has no plan to perform the reoperation for the patient.

Manufacturer Narrative

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

Manufacturer Narrative

The subject clv-260 was not returned to olympus medical systems corp.(omsc) for evaluation.However, the subject clv-260 was returned to repair center of olympus for repair.As a result of investigation by repair center, it was found that the fuse was blown.Therefore omsc concluded that this event attributed to fuse blown.Omsc surmised that there was the possibility the fuse was degraded with age and/or overcurrent was accidental applied to the subject clv-260.The clv-260 instruction manual states the corresponding method when there is an abnormality for the device.Olympus checked the device history record of the subject clv-260, there was no irregularity found.There were no further details provided.If significant additional information is received, this report will be supplemented.

• 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: 7680575
• MDR Text Key: 114453082
• Report Number: 8010047-2018-01320
• 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
• 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: 07/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CLV-260
• 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