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

Model Number N/A

Device Problems Overheating of Device (1437); Smoking (1585)

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

Event Date 11/11/2016

Event Type  malfunction  

Manufacturer Narrative

This mdr is being submitted past the 30 day reporting requirement as part of a retrospective review of the report that was initiated during an fda inspection.A retrospective review of the complaint record determined that this report should have been submitted as a malfunction report.In this case, no patient injury occurred; however, this may be likely to cause or contribute to a serious injury if it recurred.(b)(4).Investigation findings: as reported the device smoked when connected to the light source.Two products were returned and a visual examination was carried out.Images of the associated light source, xdp luxtec model 9300, utilized were also reviewed.The reported light source, xdp luxtec model 9300, is not yet available for use in investigation.Therefore, the karl storz light source was utilized for the investigation.A functional test was performed using the karl storz light source on the two returned devices, one received in an open condition and the other in an unopened package.The open device was functional and illuminated appropriately, the light source was set at 1, and there was no smoke.The unopened device functioned accordingly, the light source was set at 1, and there was no smoke.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.In addition review of device master record did not observe any nonconformances that may have contributed to this incident.Based on the provided information, a definitive root cause cannot be established or reported at this time.However, the most likely cause of this reported event may be overheating due to a high light source setting over an extended period of time.A stop ship has been executed to prevent further distribution until this issue is better understood.A capa has been opened to investigate this issue further (ref capa (b)(4)).

Event Description

The reporter alleged that the bush ureteral illuminating catheter smokes when it is connected to the xdp luxtec model 9300.There was no report of any patient injury as a result of this occurrence.

Manufacturer Narrative

(b)(4).Investigation findings: as reported the device smoked when connected to the light source.Two products were returned and a visual examination was carried out.Images of the associated light source, xdp luxtec model 9300, utilized were also reviewed.The reported light source, xdp luxtec model 9300, is not yet available for use in investigation.Therefore, the karl storz light source was utilized for the investigation.A functional test was performed using the karl storz light source on the two returned devices, one received in an open condition and the other in an unopened package.The open device was functional and illuminated appropriately, the light source was set at 1, and there was no smoke.The unopened device functioned accordingly, the light source was set at 1, and there was no smoke.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.In addition review of device master record did not observe any nonconformances that may have contributed to this incident.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the provided information, a definitive root cause cannot be established or reported at this time.However, the most likely cause of this reported event may be overheating due to a high light source setting over an extended period of time.

Event Description

The reporter alleged that the bush ureteral illuminating catheter smokes when it is connected to the xdp luxtec model 9300.There was no report of any patient injury as a result of this occurrence.Additional information rec'd 1/27/2017: user facility medsun report was received providing event details.The event description indicates that the device began to smoke about 15 to 20 seconds after being plugged into the light source.Smoke emanated from two holes where the device was plugged into the light source.A staff member reports observing a bright red center where the device was plugged.Medsun report attached.The instructions for use that accompany each device states under the precautions section that " the anodized aluminum plug conducts heat.Allow the plug to cool down prior to attempting to unplug." the instructions for use also state under the instructions for use section that: "note: 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." "note: high-energy light sources such as xenon may cause overheating of the anodized aluminum plug.An adapter (available from most light source manufacturers) will ensure product safety and functionality." "note: start illumination with the light source at the lowest setting, as many light sources produce thermal energy at varying temperatures.This will limit the possibility of thermal damage at the catheter/light plug junction.".

Manufacturer Narrative

A review of the complaint history, device history record, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.It was determined that while the design of the bush catheter was sufficient for the light sources present at the time of its design, changes in the power levels available for use in surgical theaters led to unsafe conditions.Action has been taken in response to this failure mode due to a lack of testing on methods to prevent overheating and what precise power levels lead to overheating.Measures have been conducted to address this failure mode.Monitoring will continue to be performed for similar complaints.

Event Description

It was reported that during a surgical procedure, a ureteral laminating stent was plugged into a light source (luxtec model 9300xdp).Fifteen to twenty seconds after being plugged in, staff noted smoke coming out of the light source hole above where the stent was plugged in.The surgeon reported being unable to see the stent lighted and the surgeon started to unplug it.After it was turned off, smoke came out of both holes where it was unplugged.A staff member reported seeing a bright red center at the end of the stent where it was plugged into the light source.A customer technician was reportedly able to duplicate the problem when he connected the catheter to the light source.The unit worked ok with another head set.

• 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: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6250700
• MDR Text Key: 65085582
• Report Number: 1820334-2017-00120
• Device Sequence Number: 1
• Product Code: FCS
• UDI-Device Identifier: 00827002167469
• UDI-Public: (01)00827002167469(17)190526(10)6998468
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: N/A
• Device Catalogue Number: 084120
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: Z-1870-2017
• Patient Sequence Number: 1
• Treatment: LUXTEC MODEL 9300 XDP
• Patient Age: 35 YR