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 No Display/Image (1183)

Patient Problem No Code Available (3191)

Event Date 09/04/2019

Event Type  Injury  

Event Description

The service center was informed that during an unspecified procedure, the ultrasound image was dark and grainy.The physician was unable to view the aspiration needle.The intended procedure was aborted.The user facility reported that the patient had been sedated prior to the procedure and was transported to different hospital.The patient's current condition is unknown.

• 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 192-8 507; JA 192-8507
• MDR Report Key: 9151125
• MDR Text Key: 163766005
• Report Number: 2951238-2019-01134
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 04953170343414
• UDI-Public: 04953170343414
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/04/2019,10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: Yes
• Distributor Facility Aware Date: 09/04/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/04/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention