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

Model Number N/A

Device Problems Melted (1385); Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow up report will be send upon conclusion.

Event 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.

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to product handling or user handling related.Based on the failure investigation, the product has been obsolete and withdrawn from the field.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
• Type of Device: FCS CATHETER, LIGHT, FIBEROPTIC, GLASS, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6390903
• MDR Text Key: 69751135
• Report Number: 1820334-2017-00331
• Device Sequence Number: 1
• Product Code: FCS
• UDI-Device Identifier: 00827002167469
• UDI-Public: (01)00827002167469(17)190527(10)7003797
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 084120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2017
• Date Device Manufactured: 05/27/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1