MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-08-17 for BUSH SL URETERAL ILLUMINATING CATHETER SET 084120 manufactured by Cook Urological, Inc..
[2760707]
During gall bladder surgery, the surgeon noted the stent did not light up when placed in the ureters. The nurse checked the connector on the machine and found the copper connection was extremely hot. The cord was replaced and procedure completed. No injury to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5026581 |
| MDR Report Key | 2711101 |
| Date Received | 2012-08-17 |
| Date of Report | 2012-08-17 |
| Date of Event | 2012-08-10 |
| Date Added to Maude | 2012-08-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BUSH SL URETERAL ILLUMINATING CATHETER SET |
| Generic Name | LIGHTED STENT |
| Product Code | FCS |
| Date Received | 2012-08-17 |
| Catalog Number | 084120 |
| Lot Number | U2218930 |
| Device Expiration Date | 2015-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2012-08-17 |