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 Activation Problem (4042)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2019

Event Type  malfunction  

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 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.

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
• Type of Device: UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8521834
• MDR Text Key: 142363229
• Report Number: 8010047-2019-01708
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 04953170343414
• UDI-Public: 04953170343414
• 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,health profession
• Type of Report: Initial,Followup
• Report Date: 07/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR