MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2012-09-21 for BUSH URETERAL ILLUMINATING CATHETER SET 084120 manufactured by Cook Urological, Inc..
[2889775]
The physician placed the bush illuminating catheter with no problem. The catheter was plugged into the acmi outlet of another mfr's light source. After the catheter placement, the catheter was then taped up by the abdomen and the pt was then placed in the lithotomy position. The physician believes that the catheter was then kinked and perforated and the light was escaping through the catheter below the plug in junction. This also supports the general surgeon's recollection of seeing the light illuminating through the perforation under the drape during the case. The pt suffered at least two burns that were immediately treated with ointment. At least two burns and blistering caused by catheter. The operating room staff treated burn with silvadene ointment.
Patient Sequence No: 1, Text Type: D, B5
[10134503]
The results and conclusion eval are unk due to the product not being returned. The bush ureteral illuminating catheter will not be returned, however, the nurse at the facility has indicated photos of the device will be sent once the user facility's biomedical engineering department has completed its investigation. The customer indicated that the type of light source that was being used is a xenon model. The instructions for use for the bush ureteral illuminating catheter include the following statement, "high energy light sources such as xenon may cause overheating of the anodized aluminum plug. An appropriate adapter will ensure product safety and functionality. " should add'l info become available, cook will provide it to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825146-2012-00022 |
| MDR Report Key | 2762002 |
| Report Source | 05,06,07 |
| Date Received | 2012-09-21 |
| Date of Report | 2012-08-22 |
| Date of Event | 2012-08-22 |
| Date Facility Aware | 2012-08-22 |
| Report Date | 2012-09-21 |
| Date Reported to Mfgr | 2012-08-23 |
| Date Mfgr Received | 2012-08-24 |
| Date Added to Maude | 2012-09-28 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRIS KILANDER |
| Manufacturer Street | 1100 WEST MORGAN ST. |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal | 47460 |
| Manufacturer Phone | 8128294891 |
| 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 | 2012-09-21 |
| Model Number | NA |
| Catalog Number | 084120 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK UROLOGICAL, INC. |
| Manufacturer Address | SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-09-21 |