MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. FIBERSCOPE "CYF-5", EUROPEAN VERSION; CYSTONEPHROFIBERSCOPE

Model Number CYF-5

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/13/2018

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to olympus medical systems corp.But was returned to olympus (b)(4).The subject device was sent to a third party laboratory for additional microbiological testing.In the additional test, the testing result indicated no microbial growth for the subject device.The exact cause could not be determined at present.If significant additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that during routine surveillance culturing tests at the user facility on (b)(6) 2018, the subject device tested positive for unspecified bacteria (1cfu/100ml).It was also informed that the subject device tested repeatedly positive for unspecified bacteria (5cfu/100ml) during additional culturing test at the user facility on (b)(6) 2018.The subject device had been manually reprocessed with peracetic acid.There was no report of patient infection associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information and the manufacturing date.The subject device has not been returned to olympus medical systems corp.Omsc reviewed the manufacturing history of the subject device (manufacturing date; oct.28,2015) and confirmed no irregularity.

• Brand Name: FIBERSCOPE "CYF-5", EUROPEAN VERSION
• Type of Device: CYSTONEPHROFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7913654
• MDR Text Key: 124662127
• Report Number: 8010047-2018-01874
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• PMA/PMN Number: K032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/12/2018

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
• Device Operator: Health Professional
• Device Model Number: CYF-5
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/30/2018
• Initial Date FDA Received: 09/27/2018
• Supplement Dates Manufacturer Received: 10/16/2018
• Supplement Dates FDA Received: 11/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1