MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-V2

Device Problem Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Fever (1858)

Event Date 10/18/2019

Event Type  Injury  

Event Description

The manufacturer was informed that 24 hours after a cystoscopy procedure, the patient had a fever and needed to be hospitalized.The patient's urine culture indicated that the patient contracted pseudomonas aeruginosa >100,000 cfu/ml.The patient's urine culture on (b)(6) 2019 and prior to the procedure indicated that everything was normal.The facility utilizes aldahol for reprocessing and the aldahol's efficacy is tested daily.

• Brand Name: VISERA CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9334737
• MDR Text Key: 166779781
• Report Number: 2951238-2019-01190
• 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
• Type of Report: Initial
• Report Date: 10/24/2019,11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CYF-V2
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/24/2019
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 10/24/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention