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

Model Number CYF-5

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

The device in this report has not been returned to olympus medical systems corp. (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

Several patients were infected after cystoscopy using this device. The customer did not notice anything while reprocessing or preparing the device. The user did not provide other detailed information, such as the number of infected patients or the type of microbes.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 11053855
• MDR Text Key: 223187805
• Report Number: 8010047-2020-10807
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (Y/N): N
• Reporter Country Code: GM
• PMA/PMN Number: K032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: FOREIGN,USER FACILITY

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/22/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 12/22/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: NO INFORMATION
• Device MODEL Number: CYF-5
• Was Device Available For Evaluation?: No

Is The Reporter A Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 11/27/2020
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient TREATMENT DATA

Date Received: 12/22/2020 Patient Sequence Number: 1