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

Model Number N/A

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2017

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 during a robotic procedure, the bush ureteral illuminating catheter set was very hot at the entry point where the light cord connects to the lightbox.The nurse indicated she smelled a burning smell, and it was determined that the brass fitting appeared to be overly hot.The power setting was set to 60% on the lightbox.The brand of the light box was luxtec.The customer did not specify whether or not the light source was on the entire time or if it was dimmed when not in use.The customer did state that the overheating occurred towards the end of the procedure and that they turned off the light to the catheter and continued procedure without it.There was no harm to either the patient or the staff.There were no additional procedure necessary because of the brass fitting being ¿overly hot¿.No further information was provided.

Manufacturer Narrative

A review of device history record and complaint history could not be performed as a serial or lot number was not provided.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.The instructions for use (ifu) included with the device, which 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." ¿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 was related to product use or handling related.Measures have been previously initiated to address this issue.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• 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: 6420269
• MDR Text Key: 70519529
• Report Number: 1820334-2017-00429
• Device Sequence Number: 1
• Product Code: FCS
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/14/2017

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
• 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?: Yes
• Initial Date Manufacturer Received: 02/20/2017
• Initial Date FDA Received: 03/21/2017
• Supplement Dates Manufacturer Received: 07/31/2017
• Supplement Dates FDA Received: 08/14/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1