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

Model Number 7305.001

Device Problem Break (1069)

Patient Problem Dysuria (2684)

Event Date 04/01/2014

Event Type  No Answer Provided  

Event Description

Facility notified richard wolf medical instruments corporation (rwmic) that patients reported burning sensation during urination.Patients had gone through a procedure that used the device in question.

Manufacturer Narrative

An investigation was completed as the actual device was returned to the rwmic facility on (b)(4) 2014.Optics manager found one control wire broken on proximal end of scope.Wire located under handle and would not have caused injury.Scope was also heated with light fiber, was not hot enough to burn.Device functioned normally.Could not identify anything that would have caused injury to patient.Device history: repair dates - 04/2009, 09/2013, 06/2013.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 rec'd add'l inf, we will provide fda with f/u info.

• 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: 3855663
• MDR Text Key: 20012494
• Report Number: 1418479-2014-00018
• 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: 04/23/2014

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: 04/28/2014
• Initial Date Manufacturer Received: 04/28/2014
• Initial Date FDA Received: 05/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2008
• 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