MAUDE Adverse Event Report: COOK INC BUSH URETERAL ILLUMINATING CATHETER SET; FCS CATHETER, LIGHT, FIBEROPTIC, GLASS, URETERAL

Model Number	N/A
Medical Device Problem Codes	Melted (1385); Smoking (1585)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow up report will be send upon conclusion.
Event or Problem Description
It was reported by the user facility that prior to procedure the bush ureteral illuminating catheter set began to smoke.The device was plugged into the light source when it began to heat up.The smoking occurred at the plug connecting to the light source and the device melted.No further information was provided.
Additional Manufacturer Narrative
Investigation - evaluation.A review of the complaint history, device history record, documentation, instructions for use and quality control data was conducted during the investigation.The product will not be returned for the investigation.If the device becomes available complaint will be reopened and investigation will be performed at that time.Review of production and quality documentation did not observe any specific issues with current controls that may have contributed to this incident.Review of device history record found three non-conformances but none of these non-conformances were related to the complaint failure mode.The ifu included with the device states,"this catheter will not transmit thermal energy along its light fibers to patient tissue.Any excessive thermal damage from the light source will manifest at the catheter/light plug junction, and will not be transmitted along the catheter length.And "start illumination with the light source at the lowest setting, as many light sources product thermal energy at varying temperatures.This will limit the possibility of thermal damage at the catheter/light plug junction.It is inadvisable to use any light source at its highest setting, unless the light source`s actual thermal energy output is unknown." based on the provided information, a root cause of the event was related to product handling or user handling related.Based on the failure investigation, the product has been obsolete and withdrawn from the field.

• Brand Name: BUSH URETERAL ILLUMINATING CATHETER SET
• Common Device Name: FCS CATHETER, LIGHT, FIBEROPTIC, GLASS, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6390903
• Report Number: 1820334-2017-00331
• Device Sequence Number: 442462
• Product Code: FCS
• UDI-Device Identifier: 00827002167469
• UDI-Public: (01)00827002167469(17)190527(10)7003797
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2017

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 084120
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/08/2017
• Supplement Date Received by Manufacturer: 07/14/2017
• Initial Report FDA Received Date: 03/09/2017
• Supplement Report FDA Received Date: 08/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1