MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

Model Number GF-UCT180

Device Problem Microbial Contamination of Device (2303)

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

Event Type  malfunction  

Manufacturer Narrative

The medwatch report provided an incorrect serial number for the model gf-uct180 scope; therefore, it is unknown if the device was returned olympus for evaluation and/ or service.Olympus will continue to investigate this complaint to obtain more detailed information regarding the reported event.If additional information becomes available at a later time, this report will be updated accordingly.

Event Description

Olympus received a medwatch report which states that during routine culturing the scope tested positive for positive for a carbapenem-resistant enterobacteriaceae (cre).According to the report, the scope last cultured negative on (b)(6) 2018.The scope has been used 11 times between (b)(6) and (b)(6).The scope was reportedly returned to the manufacturer for repair on april 19, 2018 and was not utilized again up to the time of the routine scope culturing.There were no associated patient infections reported.

Manufacturer Narrative

This supplemental report is being submitted to report additional information from the ess.As part of our investigation of this report, an olympus endoscopy support specialist (ess) was dispatched to the user facility to assess their reprocessing practices and to provide reprocessing training if necessary.The customer declined the ess visit.

Manufacturer Narrative

This supplemental report is being submitted to make a correction on the procode from itx to odg.

• Brand Name: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Type of Device: ULTRASOUND GASTROVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7924721
• MDR Text Key: 122465828
• Report Number: 2951238-2018-00589
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GF-UCT180
• Device Catalogue Number: GF-UCT180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1