MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-02-08 for BUSH URETERAL ILLUMINATING CATHETER SET N/A 084120 manufactured by Cook Inc.
[66776450]
(b)(4). The event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[66776451]
It was reported by the user facility that a patient underwent a robotic abdominal hysterectomy procedure using a bush ureteral illuminating catheter set. The attending physician indicated during the procedure the stent melted where the clear meets the black. No unintended sections of the device remain inside the patient? S body nor did the patient experience any additional procedures or adverse effects due to this occurrence. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2017-00184 |
| MDR Report Key | 6310304 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-02-08 |
| Date of Report | 2017-08-04 |
| Date of Event | 2017-01-17 |
| Date Mfgr Received | 2017-07-14 |
| Date Added to Maude | 2017-02-08 |
| 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 | 2017-02-08 |
| 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 | 2017-02-08 |