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

Model Number	EU-ME2 PREMIER PLUS
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject eu-me2 premier plus was returned to olympus medical systems corp.(omsc).Omsc investigated the subject eu-me2 premier plus.As a result, omsc found that ¿us1d00¿ error occurred after turned on the subject eu-me2 premier plus and the subject eu-me2 premier plus did not start up."us1d00¿ error indicates that a solid state drive (ssd) in the device is malfunctioning.Therefore, omsc determined that the cause of the reported failure, which the subject eu-me2 premier plus did not start up, was caused by a malfunction of the ssd.Omsc asked oem to investigate the subject eu-me2 premier plus to identify root cause.The eu-me2 premier plus instruction manual states the corresponding method when there is an abnormality for the device.There were no further details provided.If significant additional information is received, this report will be supplemented.
Event or Problem Description
It was reported that the disk access lamp on the front panel is lit as orange and the subject eu-me2 premier plus did not start up, when an endoscopic ultrasound-fine needle aspiration (eus-fna) was started after anaesthesia.The user cancelled the intended procedure.There was no report of the patient¿s injury regarding this event.
Additional Manufacturer Narrative
Omsc identified that the cause of the reported failure, which the subject eu-me2 premier plus did not start up, was caused by a malfunction of the internal memory (solid state drive : ssd).Omsc asked the original equipment manufacturer (oem) to investigate the subject eu-me2 premier plus to identify root cause.As a result by the oem, the evidence that the subject eu-me2 premier plus was turned off several times while accessing ssd was found.It is known that to turn off while accessing ssd may lead to damage to the ssd.Based on the investigation result so far, it was concluded that the malfunction of the ssd was attributed to that the user turned the subject eu-me2 premier plus off while accessing ssd.The eu-me2 premier plus instruction manual states that do not turn the device off during accessing internal memory and may cause malfunction of the device.

• Brand Name: EVIS EUS ENDOSCOPIC ULTRASOUND CENTER
• Common Device Name: UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8521834
• Report Number: 8010047-2019-01708
• Device Sequence Number: 1966012
• Product Code: IYN
• UDI-Device Identifier: 04953170343414
• UDI-Public: 04953170343414
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K130058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2019

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
• Operator of Device: Health Professional
• Device Model Number: EU-ME2 PREMIER PLUS
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 07/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR