MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA DUODENOVIDEOSCOPE

Model Number TJF-260V

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to omsc for evaluation.Omsc reviewed the manufacturing history (dhr) of the device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that enterococcus casseliflavus were detected from bile samples collected from 5 or 6 patients during endoscopic retrograde cholangiopancreatography (ercp) procedures using the subject device.It was reported that the ercp procedures were carried out between (b)(6) 2019 and (b)(6) 2019.All patients have not developed any symptoms of infection.As a result of microbiological testing for the subject device by the user facility, no microbial growth for the sample collected from the channel, the distal end and around of the forceps elevator of the device.The user facility reused a non-olympus disposable biopsy valve several times.However, as a result of microbiological testing by the user facility, no microbial growth for the sample collected from the disposable biopsy valve.The device had been reprocessed using an olympus automated endoscope reprocessor model oer-4 or oer-5 (not available in the usa).The user facility concluded that the cause of the reported event was not the subject device.Olympus is submitting mdr according to the number of the patients who were infected potentially associated with the endoscope.This is 6nd of 6 reports.

• Brand Name: EVIS LUCERA DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 8538532
• MDR Text Key: 142737353
• Report Number: 8010047-2019-01769
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/23/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: TJF-260V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/04/2019
• Initial Date FDA Received: 04/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other