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

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.

• Brand Name: ENDOSCOPE, URETEROSCOPE, COBRA
• Type of Device: FLEXIBLE 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 Key: 5338620
• MDR Text Key: 34929135
• Report Number: 1418479-2015-00044
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 7326071
• Device Catalogue Number: 7326071
• Device Lot Number: 5000314736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2014
• 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