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

Model Number CYF-5

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

It was reported the device is dirty [sic] and has caused patient infection. Although requested, additional information has not been received. The device was not returned to olympus for evaluation. The cause of the reported event cannot be determined. If additional information becomes available at a later time, 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: 10277107
• MDR Text Key: 199038292
• Report Number: 2951238-2020-00479
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (Y/N): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/31/2020,08/24/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 07/15/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: CYF-5
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/19/2020
• Event Location: Hospital
• Date Report TO Manufacturer: 07/31/2020
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Is The Device Single Use?: No Answer Provided
• Is this a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient TREATMENT DATA

Date Received: 07/15/2020 Patient Sequence Number: 1