MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-03-21 for BUSH URETERAL ILLUMINATING CATHETER SET N/A 084120 manufactured by Cook Inc.
[70519529]
(b)(4). The event is currently under investigation. A follow up report will be send upon conclusion.
Patient Sequence No: 1, Text Type: N, H10
[70519530]
It was reported by the user facility that during a robotic procedure, the bush ureteral illuminating catheter set was very hot at the entry point where the light cord connects to the lightbox. The nurse indicated she smelled a burning smell, and it was determined that the brass fitting appeared to be overly hot. The power setting was set to 60% on the lightbox. The brand of the light box was luxtec. The customer did not specify whether or not the light source was on the entire time or if it was dimmed when not in use. The customer did state that the overheating occurred towards the end of the procedure and that they turned off the light to the catheter and continued procedure without it. There was no harm to either the patient or the staff. There were no additional procedure necessary because of the brass fitting being? Overly hot?. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2017-00429 |
| MDR Report Key | 6420269 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-03-21 |
| Date of Report | 2017-08-14 |
| Date of Event | 2017-02-15 |
| Date Mfgr Received | 2017-07-31 |
| Date Added to Maude | 2017-03-21 |
| 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 | MRS. RITA HARDEN |
| 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 |
| 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 | 2017-03-21 |
| Model Number | N/A |
| Catalog Number | 084120 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2017-03-21 |