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 Type  Injury  

Manufacturer Narrative

The subject device has not been returned to omsc but was returned to (b)(4).The exact cause could not be determined at present, because the subject device is under the investigation.Omsc reviewed the manufacture history of the subject device and confirmed no irregularity.An olympus representative visited the user facility to obtain additional information and got following information.One of the two tjf-145 tested positive, and the bacteria detected from the scope had same strains of bacteria detected from the patients.The user had used an olympus brush (b)(4) and a non-olympus brush (pentax cs-c9s).The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available or if the device is returned at a later time, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that three patients were possibly infected with klebsiela pseudomonas producer of carbapenemasa after ercp procedures in (b)(6) 2018 (detailed date is unknown).The facility also reported that two duodenoscopes (serial number: one is (b)(4), the other is unknown) were possibly contaminated, but it was unknown which scope was used for each patient.Outcome of three patients were unknown.The user facility reported that the subject device had been reprocessed using an olympus automated endoscope reprocessor model etd-4 (not available in the usa) using peracetic acid.This report is 1 of 3 reports.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation result.The subject device was sent to olympus (b)(4) for deeper investigation.(b)(4) sent the subject device to a third party laboratory for microbiological testing and the testing indicated no microbial growth for the subject device.After the microbiological testing at the third party laboratory, the evaluation for the subject device by (b)(4) confirmed the following; the inside of the light guide lens was foggy.There were dents and scratches on the distal end cover.There was a heavy scratch on the insertion tube.The exact cause of the reported phenomenon could not be conclusively determined.This report is 1 of 3 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
• MDR Report Key: 7410636
• MDR Text Key: 104803247
• Report Number: 8010047-2018-00599
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• PMA/PMN Number: PK954451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/13/2018
• Initial Date FDA Received: 04/10/2018
• Supplement Dates Manufacturer Received: 04/19/2018; 02/13/2019
• Supplement Dates FDA Received: 05/15/2018; 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other