MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2017-01-13 for BUSH URETERAL ILLUMINATING CATHETER SET N/A 084120 manufactured by Cook Inc.
[65085582]
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)).
Patient Sequence No: 1, Text Type: N, H10
[65085583]
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.
Patient Sequence No: 1, Text Type: D, B5
[70877213]
(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.
Patient Sequence No: 1, Text Type: N, H10
[70877214]
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. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2017-00120 |
| MDR Report Key | 6250700 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2017-01-13 |
| Date of Report | 2017-07-20 |
| Date of Event | 2016-11-11 |
| Date Mfgr Received | 2017-06-29 |
| Device Manufacturer Date | 2016-05-26 |
| Date Added to Maude | 2017-01-13 |
| 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 |
| 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 | 2017-01-13 |
| Model Number | N/A |
| Catalog Number | 084120 |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2017-01-13 |