MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORPORATION EVIS EXERA II DUODENOVIDEOSCOPE

Model Number TJF-Q180V

Device Problem Contamination (1120)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The exact cause of the patient's outcome could not be conclusively determined at this time.As part of our investigation, olympus dispatched an endoscopy support specialist (ess) to the user facility to observe their reprocessing practices.At this time the user facility has not yet scheduled a date for the in-service.If additional and significant information becomes available at a later time, this report will be supplemented.

Event Description

Olympus was informed that a patient contracted a carbapenem-resistant enterobacteriaceae (cre) infection during an endoscopic retrograde cholangiopancreatography (ercp) procedure.It was also reported that the duodenovideoscope was reprocessed with a custom ultrasonics automated endoscope reprocessor (aer).The patient underwent multiple procedures using a duodenovideoscope between (b)(6) 2014 and (b)(6) 2015.No additional information was provided.Olympus followed up with the user facility to obtain additional information regarding the reported event via telephone and in writing but with no result.

• Brand Name: EVIS EXERA II DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEM CORPORATION; 2951 ishikawa-cho,; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: donny shapiro ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355161
• MDR Report Key: 5414068
• MDR Text Key: 37612164
• Report Number: 2951238-2016-00061
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TJF-Q180V
• Device Catalogue Number: TJF-Q180V
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Life Threatening; Other