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

Model Number CLV-260SL

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

The device in this report has not been returned to olympus medical systems corp.(omsc) for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

At the beginning of endoscopic retrograde cholangiopancreatography (ercp), no endoscopic image was displayed on the monitor.The physician was inserting the endoscope into the patient when the problem occurred.The physician then withdrew the scope and stopped using the device.When this phenomenon occurred, the patient was not under anesthesia yet.The start of the procedure was delayed, but the user completed the procedure.There was no report of patient injury associated with this event.The user facility did not provide other detailed information.

Manufacturer Narrative

This supplemental report is being submitted to report the withdrawal of mfr report #8010047 - 2020 - 10789.Olympus re-evaluated the event reported in the initial report and determined that the failure mode is not an mdr reportable malfunction.Therefore, this report is being submitted to retract the mdr on the event.

• 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 192-8 507; JA 192-8507
• MDR Report Key: 11052841
• MDR Text Key: 225930295
• Report Number: 8010047-2020-10789
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• 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: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1