MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORP. OLYMPUS FLEXIBLE CYSTONEPHROFIBERSCOPE; CYSTOSCOPE

Model Number CYF-5

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

Patient Problem Urinary Tract Infection (2120)

Event Type  Injury  

Event Description

Olympus was informed that three pts tested positive for urinary tract infections after undergoing a cystoscopy procedures.It was stated that the dates of events occurred over several months.It was also reported that the device had not failed leak test.Olympus followed up with the user facility via telephone and in writing regarding the reported event, but with no results.

Manufacturer Narrative

The device referenced in this report has been returned to olympus for eval.However, as part of our investigation process, the device has been forwarded to an off-site independent laboratory for micro-biological testing.Upon return of the device a physical eval will be performed.The exact cause of the pt's outcome could not be conclusively determined at this time.A review of the device history records showed no anomalies, with the mfg process.If additional info becomes available at a later time, this report will be supplemented.Please cross reference the associated complaint files: mfr report #: 2951238-2015-00087.

• Brand Name: OLYMPUS FLEXIBLE CYSTONEPHROFIBERSCOPE
• Type of Device: CYSTOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEM CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo 192- 8507; JA 192-8507
• Manufacturer Contact: noemi schambach ; 2400 ringwood ave.; san jose, CA 95131 ; 4089355002
• MDR Report Key: 4539385
• MDR Text Key: 5357717
• Report Number: 2951238-2015-00089
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CYF-5
• Device Catalogue Number: CYF-5
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/06/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other