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

Model Number TJF-Q180V

Device Problem Microbial Contamination of Device (2303)

Patient Problem Unspecified Infection (1930)

Event Date 07/02/2020

Event Type  Injury  

Manufacturer Narrative

The equipment was reprocessed for possible contamination of the patient.Additional event information has been requested but not received.The device was not returned to olympus for evaluation.The cause of the reported event cannot be determined.If additional information becomes available at a later time, this report will be supplemented.

Event Description

It was reported the patient underwent an endoscopic ultrasound (eus) and endoscopic retrograde cholangiopancreatography (ercp) on (b)(6) 2020 during which the gf-uct180 and the tjf-q180v duodenoscope were used.Non-frank hilar stenosis and incomplete drainage of contrast medium was identified.Subsequently, a second ercp was performed on (b)(6) 2020 using the tjf-q180v duodenoscope.During the procedure a 8 mm x 40 mm self-expanding metallic biliary prosthesis was placed to covered in the right liver branch, unable to drain the left liver branch, presenting after the procedure severe cholangitis in the patient, the pseudomonas aeruginosa was isolated on (b)(6) 2020.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information received from the customer, the device history record review (dhr), legal manufacturer's investigation, and a correction to the initial report.Correction: aware date (b)(6) 2020 for e1.The customer also reported: it is unknown what cleaning and disinfectant solutions were used with the endoscope.It is unknown how off the minimum effective concentration is being checked.It is unknown what type of aer is being used to reprocess the endoscopes.It is unknown if the endoscope channel is being brushed during manual cleaning.The scope was pre-cleaned immediately after the procedure by following the cleaning process.The scope was not being leak tested prior to the manual cleaning.No problems were noted with the automated endoscope reprocessors (aers).There was no flushing or air into the endoscope channel after reprocessing.Site received a reprocessing in-service august 2020.The site did not have a change in the reprocessing personal from the time the in-service occurred to when the issue happened.All reprocessing personnel are properly trained on how to reprocess and endoscope.The site does not wish to have an endoscopy support specialist conduct a site visit for another reprocessing in-service.Scope storage - delivered to client.The dhr for this device were reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.A definitive root cause was not identified.Based on the available information, the legal manufacturer could not determine the relationship between the patient's positive culture and the subject device.The subject device was not culture tested.

Event Description

Additional information received from customer: there was a procedural delay of an unknown length of time.The patient was treated for the infection, however treatment course is unknown.No defects detected with devices.Scope not cultured.

Manufacturer Narrative

This supplemental report is being submitted to provide the additional information received from the customer.The following field was updated: b5.Procedure date corrected to (b)(6) 2021.

Event Description

Additional information from customer: the procedure was performed on (b)(6) 2021.The procedural delay was due to the incomplete draining of the left hepatic branch.The patient is reported to be "recovered" and the biliary prosthesis was removed (b)(6) 2020.

• Brand Name: EVIS EXERA II 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
• MDR Report Key: 10381831
• MDR Text Key: 202261940
• Report Number: 8010047-2020-05390
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170367311
• UDI-Public: 04953170367311
• Combination Product (y/n): N
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2021

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: TJF-Q180V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/14/2020
• Initial Date FDA Received: 08/07/2020
• Supplement Dates Manufacturer Received: 08/25/2021; 09/28/2021
• Supplement Dates FDA Received: 09/21/2021; 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other