MAUDE Adverse Event Report: OLYMPUS AMERICA, INC. FLEXIBLE CYSTO-NEPHRO FIBERSCOPE; CYSTOSCOPE AND ACCESSORIES, FLEXIBLE

Model Number CYF-5

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 02/04/2014

Event Type  malfunction  

Event Description

After the procedure, the cystoscope failed the leak test.The cystoscope was sent to sterilization for evaluation.

• Brand Name: FLEXIBLE CYSTO-NEPHRO FIBERSCOPE
• Type of Device: CYSTOSCOPE AND ACCESSORIES, FLEXIBLE
• Manufacturer (Section D): OLYMPUS AMERICA, INC.; 3500 corporate pkwy; center valley, pa 18034 PA 18034
• MDR Report Key: 3644147
• MDR Text Key: 4351262
• Report Number: 3644147
• Device Sequence Number: 1
• Product Code: FAJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 02/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: CYF-5
• Device Catalogue Number: CYF-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/14/2014
• Device Age: 4 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/25/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2014
• Patient Sequence Number: 1
• Patient Age: 59 YR