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 Known Impact Or Consequence To Patient (2692)

Event Date 04/11/2016

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, it may be likely to cause or contribute to a serious injury if patient contact did occur.(b)(4).Investigation findings: the complaint device was not returned for investigation.Per the customer¿s statement ¿the black material overheated¿.A document review was conducted.Device functionality is tested 100% to assure no debris or damage during quality control process.Cook inc.Has received similar reports of this device melting at this junction.According to our previous investigations, the most likely cause is overheating due to a high light source setting over an extended period of time.Cook inc.Has received adverse event reports related to this issue.The ifu (t_bdlslc_rev0) recommends the following: the anodized aluminum plugs on the light guides fit a standard circon-a.C.M.I light source.If using a different light source, an adapter may be required to successfully use the bush dl or bush sl ureteral illuminating catheter.Adapters are available from various light source manufacturers.The ifu also provides the following note: "start illumination with the light source on 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.It is inadvisable to use any light source at its highest setting, unless the light source's actual thermal energy output is known." additionally, the ifu notes: "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." two additional requests were made for product return.However, the complaint device was not returned; therefore, a physical examination of the complaint device could not be performed.If the complaint device becomes available for investigation, the device will be evaluated and the file will be updated at that time.The light source used was the integra luxtec mlx light box.Although requested, cook inc.Was not able to determine the setting for the light source.A review of the device history record did not indicate any manufacturing anomalies.During manufacturing this device is illuminated and inspected using a storz light source at a controlled setting.The ifu also states, ¿a variety of light sources may be used.The supplied plug fits a standard circon- a.C.M.I.Light sources mv9082, mv9083 and alv-1.Storz, olympus and other light sources may be used.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.For storz xenon light source, use "turret adapter 487uo." conclusion: the most likely cause of this reported event is 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

It is alleged that the bush ureteral illuminating catheter was utilized via cystoscopy.The illuminating catheter was placed directly into the integra light box and overheated the black material where the lighted stents are inserted.The catheters were immediately removed and there was no intervention reported.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation - evaluation.A review of the complaint history, drawings, documentation, instructions for use (ifu), manufacturing instructions, specifications, and quality control was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed; however, a document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Though the complaint device was not returned for physical examination; high-level probable causes for this failure mode have been determined to be related to a design deficiency.Measures have been conducted to address this failure mode.Monitoring will continue to be performed for similar complaints.

• 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: 6250682
• MDR Text Key: 64917258
• Report Number: 1820334-2017-00119
• Device Sequence Number: 1
• Product Code: FCS
• UDI-Device Identifier: 00827002167469
• UDI-Public: (01)00827002167469(17)190215(10)6736529
• 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: company representative
• Reporter Occupation: Nurse
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 07/18/2017

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 084120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2017
• Date Device Manufactured: 02/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1870-2017
• Patient Sequence Number: 1
• Treatment: INTEGRA - LUXTEC MLX LIGHT BOX