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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP. FLEXIBLE FIBER-URETHRO-CYSTOSCOPE; FLEXIBLE CYSTOSCOPE
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RICHARD WOLF MEDICAL INSTRUMENTS CORP. FLEXIBLE FIBER-URETHRO-CYSTOSCOPE; FLEXIBLE CYSTOSCOPE Back to Search Results
Model Number 7305.006
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Date 02/01/2014
Event Type  malfunction  
Event Description
Device not working properly.
 
Manufacturer Narrative
Several attempts have been made to gather add'l info about complaint from facility and have been unsuccessful to date.An investigation was completed as the actual device was returned to the rwmic facility on 03/03/2014.Distal end was found squeezed about 1/2" from tip.Boot cause is handling.Repair dates: 08/16/2013 and 11/19/2013.Richard wolf considers this matter closed.However, in the event we receive add'l info, we will provide fda with f/u info.
 
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Brand Name
FLEXIBLE FIBER-URETHRO-CYSTOSCOPE
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 Key4232254
MDR Text Key4975965
Report Number1418479-2014-00019
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/12/2014
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 Number7305.006
Device Catalogue Number7305.006
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/12/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/12/2014
Initial Date FDA Received05/16/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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