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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC) ENDOSCOPE, URETEROSCOPE, COBRA FLEXIBLE URETEROSCOPE

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RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC) ENDOSCOPE, URETEROSCOPE, COBRA FLEXIBLE URETEROSCOPE Back to Search Results
Model Number 7326071
Device Problems Break (1069); Failure to Fold (1255); Hole In Material (1293)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

Actual device returned for investigation on 12/21/2015. Product appeared to be used. Upon visual and functional testing, with a microscope and leak tester, hole was found about 3" from distal hose and broken bowden wire. Hole allowed moisture to penetrate into system making it hard for internal wires to glide and distal hose to flex. In addition, over time moisture causes wire to corrode and easily break when device is used. Unable to determine what made the hole in the distal hose. Not a manufacturing issue. When the deflection cable breaks, the hose goes flacid and does not whip backwards therefore there is minimal risk of injuring patient. No injuries to patient or staff were reported. Manufacture date: 10/15/2014. Purchase date: (b)(4) 2015. One similar complaint on this specific product by the same reporter in the last three years (mdr1418479-2013-00005). Initial reporter has be contacted in an effort to gather missing information (ie patient information. ), no response as of 12/31/2015. Labeling was reviewed and found to be adequate. Ie intended use, indications and field of use, preparation and cautions. Rwmic considers this matter closed. However, in the event additional information is received, rwmic will provide fda with follow-up information.

 
Event Description

Distributor representative contacted richard wolf medical instrumentation corporation (rwmic) and revealed that during a procedure the device in question stopped flexing. A back up device was not readily available and approximately 20 minutes elapsed before a replacement device was obtained. Procedure then continued and completed without any physical injury to patient. Report is being submitted due to the delay in procedure where patient may have been put at risk.

 
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Brand NameENDOSCOPE, URETEROSCOPE, COBRA
Type of DeviceFLEXIBLE URETEROSCOPE
Manufacturer (Section D)
RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC)
353 corportate woods parkway
vernon hills IL 60061 3110
Manufacturer (Section G)
RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC)
353 corportate woods parkway
vernon hills IL 60061 3110
Manufacturer Contact
dawn clark
353 corportate woods parkway
vernon hills, IL 60061-3110
8003239653
MDR Report Key5338620
MDR Text Key34929135
Report Number1418479-2015-00044
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK980401
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation
Type of Report Initial
Report Date 12/04/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/31/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL Number7326071
Device Catalogue Number7326071
Device LOT Number5000314736
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/21/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/15/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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