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

Model Number TJF-Q180V

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Type  Death  

Manufacturer Narrative

The subject device has not been returned to olympus medical systems corp.(omsc) for evaluation but returned to (b)(4) on january 16,2017.The subject device is under evaluation by (b)(4).Omsc reviewed the manufacture history of the subject device and confirmed no irregularity.The exact cause could not be determined at present, if significant additional information is received, this report will be supplemented.

Event Description

Olympus (b)(4) was informed that five patients tested positive for oxa48 producing klebsiella pneumonia after having undergone endoscopic retrograde cholangiography (ercp) using the subject device between (b)(6) 2016 at the facility.The facility reported that four patients are doing well except for one patient ((b)(6)) who deceased of the patient¿s pathology.There was no other detailed information on the cause of the death of the one patient at present.The subject device was reprocessed using non-olympus automated endoscope reprocessor (solscope series 4) and the forceps elevator was replaced according to an olympus field corrective action on october 5,2016.The facility conducted additional microbiological test for the subject device on january 3, 2017 and confirmed the result cleared the criteria of french guideline of (b)(6) 2007 (elements of quality assurance in health related to the microbiological of endoscopes control and traceability in endoscopy).The routine microbiological test of the subject device, which was conducted by the facility before the procedure for the patients, reportedly cleared the guideline this is one of five report.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation result.Olympus followed up the facility to obtain additional information and was informed that the facility confirmed that the death of the patient was not attributed by the infection but due to her pre-existing pathology.The subject device has not been returned to olympus medical systems corp.But was returned to olympus (b)(4).Following additional high level disinfection at (b)(4), the subject device was send to a third party laboratory for additional microbiological testing.In the additional test, the testing result obtained for the subject device was defined as target level according to the statement by (b)(6).This is one of five reports.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus followed up the facility to obtain additional information on the reprocessing practice at the user facility and was informed that the facility had cleaned the distal end of the subject device with olympus brush (maj-1888) and had cleaned the instrument channel with non-olympus brush (kit 1-clean 1.8mm, prince medical).Except for the use of non-olympus brush, there was no deviation from the instructions of olympus reprocessing manual.Olympus provided reprocessing training for the user facility.This is one of five reports.

Manufacturer Narrative

The date received by manufacturer in the follow up number 2 was not (b)(6) 2016 but (b)(6) 2017.

• Brand Name: EVIS EXERA II DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo-to ; 8142642517
• MDR Report Key: 6295617
• MDR Text Key: 66314721
• Report Number: 8010047-2017-00106
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TJF-Q180V
• Other Device ID Number: 04953170229503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2015
• 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): Death