MAUDE Adverse Event Report: OLYMPUS AMERICA, INC. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number OLYMPUS GF TYPE UCT180

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Information (3190)

Event Date 04/30/2018

Event Type  malfunction  

Event Description

Upon performance of routine eus scope cultures, the scope was found to be positive for a cre - carbapenem resistant enterobacter.The last negative culture for this scope was (b)(6) 2018.Between (b)(6), the scope was used 11 times.The scope was sent out for repair and returned april 19, 2018 and was not used again up to the time of the routine eus scope culturing.

• Brand Name: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): OLYMPUS AMERICA, INC.; 3500 corporate parkway; center valley PA 18034 0610
• MDR Report Key: 7595941
• MDR Text Key: 110924704
• Report Number: 7595941
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: OLYMPUS GF TYPE UCT180
• Device Catalogue Number: GF-UCT180
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/08/2018
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1