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

Catalog Number J-BICS-058020

Device Problem Material Separation (1562)

Patient Problem Burn(s) (1757)

Event Date 10/23/2014

Event Type  Injury  

Event Description

Doctor started surgery with cystoscopy for endometriosis.During the surgery doctor decided to do laparoscopy.Laparoscopy wasn't enough so they moved to laparotomy.After laparoscopy they took the illuminating catheter out and left it to lie on top of patient's leg.They also had to move the power source to make more room for the next procedure.They kept lights on the catheter and after a while they noticed a smell like something was burning.After surgery they noticed that the illuminating catheter was broken and had burned the covers under the catheter and also burned a small mark on the patients leg.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Event is still under investigation.

Manufacturer Narrative

During investigation, a review of functional test, complaint history, drawings, instructions for use (ifu), manufacturing instructions (mi), quality control (qc) procedures, and a visual inspection was conducted.One used product was returned for evaluation.Customer stated "the light stent had snapped during an operation and the black part from the point of snapping had melted onto the patient's leg bag.This was noticed when the smell of burning was noticed in the theatre.The wire was hot both from where it had broken and the adapter end, so it could not immediately be detached from the light source." the returned catheter was examined.The black optical fiber seemed to have been placed under tensile force while at a high temperature.As can be seen in the investigation photos, the black material of the fiber had been necked down and snapped off at the interface of the trt tubing.The optical fiber/trt bond did not break.There was no evidence to suggest the product was not made to specification.A functional test was performed in the engineering lab with a sample device and another manufacturers light source.The catheter was plugged in, turned to the highest light intensity setting and placed on the benchtop for an extended period of time (>4 hours.) no melting or damage due to heat was cased along the length of the entire device.The proximal aluminum hub became warm to the touch, but not so hot it would bum.The experiment was repeated after forcing a failure (snapping light cable in half inside sheath) with the same results.There was a small amount of warmth coming from the damaged area where the light was dispersed instead of forced to travel down the fiber, but there was not enough heat to cause melting.The ifu states "note: high-energy light sources such as xenon may cause overheating of the anodized aluminum plug.An appropriate adapter (available from most light source manufacturers) will ensure product safety and functionality." attachment complaint communication states that the light source used was a xenon light source.Evidence displayed indicated the device had been exposed to high energy too long.When the device was draped over the patient's leg and the light source moved, the plug made contact with the catheter cable, causing it to melt as well as bum the patients leg.The appropriate internal personnel have been notified and monitoring for similar complaints will continue.

Event Description

Doctor started surgery with cystoscopy for endometriosis.While in progress the doctor decided to do laparoscopy, but then reconsidered to laparotomy.After laparoscopy they took the illuminating catheter out and placed it on top of the patient's legs they also moved the power source leaving the lights on at the catheter.After awhile a burning odor was detected.After completion of the procedure, they noticed that the illuminating catheter was broken and had burned the covers under the catheter and caused a small burn mark on the patient's leg.The patient did not require any additional procedures due to this occurrence.

• Brand Name: BUSH SINGLE LUMEN URETERAL ILLUMINATING CATHETER SET
• Type of Device: FCS CATHETER, LIGHT FIBEROPTIC, GLASS, URTERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool, manager ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4287597
• MDR Text Key: 5189687
• Report Number: 1820334-2014-00611
• Device Sequence Number: 1
• Product Code: FCS
• UDI-Device Identifier: 00827002167377
• UDI-Public: (01)00827002167377(17)170501(10)4992427
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K923436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown,distributor,foreign
• Reporter Occupation: Unknown
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2017
• Device Catalogue Number: J-BICS-058020
• Device Lot Number: 4992427
• Other Device ID Number: (01)00827002167377(17)17050(10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/23/2014
• Device Age: 5 MO
• Event Location: Hospital
• Date Manufacturer Received: 10/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2014
• 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
• Patient Outcome(s): Required Intervention