MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EUS ENDOSCOPIC ULTRASOUND CENTER; UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER

Model Number EU-ME2 PREMIER PLUS

Device Problem Unintended Movement (3026)

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

Event Date 02/15/2019

Event Type  malfunction  

Manufacturer Narrative

The subject eu-me2 premier plus has not returned to olympus medical systems corp.(omsc) for evaluation yet.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

During the ebus-tbna with the eu-me2 premier plus, the error cord ¿es9a08¿ was displayed on the ultrasound image of the monitor.The user canceled the ebus-tbna.There was no report of the patient injury other than above.

Manufacturer Narrative

The subject eu-me2 premier plus was not returned to olympus medical systems corp.(omsc) for evaluation.The information of error es9a08 was wrong.The correct error code was us9a08.The error us9a08 means that version of the software of eu-me2 premier plus is not appropriate for connecting endoscope.When using eu-me2 premier plus in combination with bf-uc290f, the software of eu-me2 premier plus needs to be updated to version 5.1 by service engineer.Therefore omsc concluded that this phenomenon occurred because the software of the subject device was not version 5.1.

• Brand Name: EVIS EUS ENDOSCOPIC ULTRASOUND CENTER
• Type of Device: UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8407187
• MDR Text Key: 139328238
• Report Number: 8010047-2019-01241
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• PMA/PMN Number: K130058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 04/03/2019

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: Health Professional
• Device Model Number: EU-ME2 PREMIER PLUS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2019
• Initial Date FDA Received: 03/11/2019
• Supplement Dates Manufacturer Received: 03/08/2019
• Supplement Dates FDA Received: 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1