MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-10-31 for BUSH URETERAL ILLUMINATING CATHETER SET 084510 manufactured by Cook Urological, Inc..
[968199]
"during a laparoscopic colon surgery, one of our younger surgeons managed to transect the ureter. "
Patient Sequence No: 1, Text Type: D, B5
[8210186]
A proper eval cannot be performed due to the prod not being returned. At this time, we are unable to confirm the part number involved. The physician indicated the prod involved was a ureteral illuminating catheter set. The physician also did not indicate if the pt rec'd any add'l procedures to aid the transsected ureter or if there was any add'l harm to the pt. Numerous attempts to speak with the physician who reported this incident to gain add'l info have been unsuccessful. Add'l investigation as well as continued attempts to speak with the physician are currently underway. As add'l info becomes available, it will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825146-2008-00035 |
| MDR Report Key | 1218128 |
| Report Source | 05,06 |
| Date Received | 2008-10-31 |
| Date Mfgr Received | 2008-10-02 |
| Date Added to Maude | 2008-11-10 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | TAMMY BACON, MGR |
| 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 | 2008-10-31 |
| Model Number | NA |
| Catalog Number | 084510 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1270799 |
| Manufacturer | COOK UROLOGICAL, INC. |
| Manufacturer Address | SPENCER IN 47460 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2008-10-31 |