MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2016-06-28 for BUSH URETERAL ILLUMINATING CATHETER SET 084120 manufactured by Cook Inc.
[48344878]
(b)(4). The event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[48344879]
During an endometriosis o a female patient, after the catheters had been installed and the lightsource had been on for only 5 minutes, the connection between the lightsource plug and the cord started to melt. The light in the catheters went out. According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
[70876504]
(b)(4). Investigation - evaluation a review of the complaint history, device history record, documentation, instructions for use (ifu), quality control and visual inspection of the returned device was conducted during the investigation. One (1) used device was returned for evaluation. The used product appeared melted at the catheter/light connection. Both the outer sheathing and the clear fiber appeared melted proximal to the junction. One (1) unused device was returned for evaluation. The device was connected to a light source and the instructions for use were followed; setting the light source at the lowest setting. The device appeared to work as described. 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. The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: "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: 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 information provided, examination and functional testing of the returned devices and the results of our investigation the failure of the device at the junction of the catheter/light plug junction matches a root cause of the device being subjected thermal energy beyond its design. Per the quality engineering risk assessment no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[70876505]
The customer reported that the connection between the light source plug and the cord started to melt. The device was in use for an endometriosis procedure of a female patient. The connection started to melt five (5) minutes after the catheters were installed and the light source turned on; the light in the catheters went out. The power setting of the light source is not known. The light source was a maxenon xenon xi-300. The procedure was completed without the use of catheters. According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence. 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. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2016-00558 |
| MDR Report Key | 5755531 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2016-06-28 |
| Date of Report | 2017-07-18 |
| Date of Event | 2016-05-26 |
| Date Facility Aware | 2016-05-26 |
| Date Mfgr Received | 2017-06-30 |
| Device Manufacturer Date | 2015-12-24 |
| Date Added to Maude | 2016-06-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1870-2017 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BUSH URETERAL ILLUMINATING CATHETER SET |
| Generic Name | FCS CATHETER, LIGHT, FIBEROPTIC, GLASS, URETERAL |
| Product Code | FCS |
| Date Received | 2016-06-28 |
| Model Number | NA |
| Catalog Number | 084120 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-28 |