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

Model Number TJF-145

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 06/12/2017

Event Type  Injury  

Manufacturer Narrative

The subject devices have not been returned to olympus medical systems corp.(omsc) for evaluation since the result of additional microbiological testing by the facility for the subject devices were negative.Omsc reviewed the manufacture history of the subject devices and confirmed no irregularity.Olympus representative inspected the etd-3 and etd-4 and confirmed no irregularity.The exact cause could not be determined at present but inappropriate storage and reprocessing practice at the user facility cannot be ruled out as the cause of this event.

Event Description

The facility reported that two patients with infection by enterobacter cloacae complex have been detected and duodenoscopes were suspected to be the cause of the infection since both patients underwent an endoscopic retrograde cholangiopancreatography (ercp).The facility also reported that it possessed three tjf-145(serial number (b)(4)) but could not identify which tjf-145 was used for these two patients.The facility reportedly had been brushing the tjf-145 using olympus brushes (model mh-507, bw-20t and maj-1534) and reprocessing them using olympus automated endoscope reprocessor model etd-3 and etd-4 (not available in the usa) the facility reportedly informed the olympus representative that it had previously been using the mh-507 brush for brushing of distal end of the tjf-145, but after the quality information (filed safety corrective action in 2017) from olympus, the facility has used the model maj-1534 brush.Olympus followed up with the facility and was informed of the following additional information.One patient underwent the ercp on (b)(6) 2017 and the other patient underwent the ercp on (b)(6) 2017.During manual cleaning, the facility did not flush all of the channels of the subject devices with detergent solution and did not brush the air/water valve and suction valve of the subject devices.During storage, the facility did not hang the subject devices vertically according to olympus instruction manual and the facility laid the subject devices on rags.In addition, the facility did not detach the endoscope accessories such as suction valve and water resistant cap.The facility inspected the subject devices and confirmed no debris and no abnormality in the appearance.In the microbiological testing for the subject devices by the facility after this event, the testing indicated no microorganism growth for the subject devices.The patients were getting well and were discharged from the user facility.This is two of two reports.

Manufacturer Narrative

This supplemental report is submitting to correct "device product code".

• Brand Name: EVIS EXERA DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 6700085
• MDR Text Key: 79574530
• Report Number: 8010047-2017-00865
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK954451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2019

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: No Information
• Device Model Number: TJF-145
• Other Device ID Number: 04953170339950
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/12/2017
• Initial Date FDA Received: 07/11/2017
• Supplement Dates Manufacturer Received: 02/13/2019
• Supplement Dates FDA Received: 02/22/2019
• 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): Other