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

Model Number TJF-Q190V

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Information (3190)

Event Date 04/06/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to omsc but was returned to olympus (b)(4).(ofr).Ofr sent the device to a third party laboratory for microbiological testing.As a result of the testing, no microbe was detected from the sample collected from the distal end and the instrument, the air/water channels of the device.As a result of the testing, the sample collected from the suction channel of the device tested positive for gram-positive bacteria (1 cfu/endoscope) the testing result cleared the french guideline.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that on april 6th, 2020, as a result of microbiological testing by the user facility, following microbes were detected from the sample collected from the subject device.Acinetobacter baumannii (20 cfu/100ml) the device had been reprocessed with a non-olympus automated endoscope reprocessor, soluscope serie4, using peracetic acid.The subject device was used on a patient carrying the germ acinetobacter baumannii with kpc-type carbapenemases on feb 27th, 2020.From february 27th to april 6th, 12 patients had ercp with this duodenoscope.No evidence of contamination on the 12 patients has confirmed, the patients were not contacted yet by the hospital.There was no report of infection associated with this report yet.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Omsc was informed by user that no patient contamination has been identified as to date.The subject device has not been returned to omsc but was returned to olympus (b)(4).(b)(4) sent the device to a third party laboratory for microbiological testing.As a result of the testing, no microbe was detected from the sample collected from the distal end and the instrument, the air/water channels of the device.As a result of the testing, the sample collected from the suction channel of the device tested positive for coagulase-negative staphyloccoci (1 cfu/endoscope) the testing result cleared the french guideline.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The distal end unit of the subject device was returned to olympus medical systems corp.(omsc) for evaluation.In the evaluation of omsc the following was confirmed; there was the brownish area on arm-cover glue at distal end side of the distal end section.The brownish area might be crevice corrosion, which was generated by humidity invaded glue surface at distal end side of the distal end section.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.There was high possibility that the discoloration of the distal end section was attributed to corrosion of the distal end section due to the crevice corrosion at peeled interface between stainless and glue, not due to biofilm, which causes generating germs.The exact cause of the reported phenomenon could not be conclusively determined.If additional information becomes available, this report will be supplemented.

• Brand Name: EVIS EXERA III 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 10050384
• MDR Text Key: 222564422
• Report Number: 8010047-2020-02681
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K193182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-Q190V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2018
• 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