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

Model Number	PCF-H180AI
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has not been returned to omsc but was returned to olympus (b)(4).(b)(4) sent the subject device to a third party laboratory for microbiological testing.As a result of the testing, the sample collected from all channels of the subject device tested positive for gram-positive bacteria (1 cfu/endoscope).The testing result cleared the (b)(4) 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 or Problem Description
Olympus medical systems corp.(omsc) was informed that as a result of multiple microbiological testing by the user facility, the following microbes were detected from the sample collected from the subject device.-suction channel and instrument channel: serratia marcescens (2 cfu/25ml).-instrument channel: serratia marcescens (11 cfu/50ml) and pseudomonas aeruginosa (2 cfu/50ml).The device had been reprocessed with a non-olympus automated endoscope reprocessor, soluscope 3 and soluscope 4, and sometimes manually reprocessed using peracetic acid.There was no report of infection associated with this report.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.If additional information becomes available, this report will be supplemented.

• Brand Name: EVIS EXERA II COLONOVIDEOSCOPE
• Common Device Name: COLONOVIDEOSCOPE
• 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: 9126718
• Report Number: 8010047-2019-03398
• Device Sequence Number: 11356258
• Product Code: FDF
• UDI-Device Identifier: 04953170339875
• UDI-Public: 04953170339875
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K100584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PCF-H180AI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/29/2019
• Supplement Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 10/18/2019
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown