MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP. CYSTOSCOPE, FLEXIBLE, 15FR; FLEXIBLE CYSTOSCOPE

Model Number 7305.001

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

Patient Problem Dysuria (2684)

Event Date 06/01/2014

Event Type  Injury  

Event Description

Facility notified richard wolf medical instruments corporation (rwmic) that patient reported severe burning sensation during urination.Patient was sent for ct scan as a result of the pain.No injury to staff reported.

Manufacturer Narrative

An investigation was completed as the actual device was returned to the rwmic facility on (b)(4) 2014.Optics manager found no issues with scope.Could not identify anything that would have caused injury to patient.Device history: manufacture date: december 2013; purchase date: (b)(4) 2014; repair date: (b)(4) 2014.Labeling was reviewed and found to be adequate.Ie intended use, indications and field of use, preparation and cautions.Richard wolf considers this matter closed.However, in the event we receive additional information, we will provide fda with follow-up information.

• Brand Name: CYSTOSCOPE, FLEXIBLE, 15FR
• Type of Device: FLEXIBLE CYSTOSCOPE
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP.; 353 corporate woods pkwy.; vernon hills IL 60061
• Manufacturer Contact: dawn clark ; 353 corporate woods pkwy.; vernon hills, IL 60061 ; 8479558016
• MDR Report Key: 3952004
• MDR Text Key: 21997862
• Report Number: 1418479-2014-00035
• 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
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/20/2014

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: Health Professional
• Device Model Number: 7305.001
• Device Catalogue Number: 7305.001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/25/2014
• Initial Date Manufacturer Received: 06/25/2014
• Initial Date FDA Received: 07/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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