MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE

Model Number CYF-5

Device Problem Microbial Contamination of Device (2303)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

The service center was made aware that two patients cultured positive for salmonella. This is for report 1 of 2.

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• 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: 9238641
• MDR Text Key: 163761527
• Report Number: 2951238-2019-01167
• 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: OTHER HEALTH CARE PROFESSIONAL
• Type of Report: Initial
• Report Date: 10/02/2019,10/25/2019

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 10/25/2019
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: CYF-5
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/02/2019
• Event Location: AMBULATORY SURGICAL Facility
• Date Report TO Manufacturer: 10/02/2019
• 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: 10/25/2019 Patient Sequence Number: 1