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 Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to omsc for evaluation.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 as a result of microbiological testing by the user facility, following microbes were detected from the sample collected from the device.-bacillus cereus, coagulase-negative staphylococcus and environmental germs the device was disinfected but these microorganisms were detected twice.Other detailed information such as the reprocessing method was not provided.There was no report of infection associated with this report.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The exact cause of the reported event could not be conclusively determined.If additional information becomes available, this report will be supplemented.

• 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 192-8 507; JA 192-8507
• MDR Report Key: 10660198
• MDR Text Key: 223662942
• Report Number: 8010047-2020-07537
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CYF-5
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1