MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-19 for BUSH URETERAL ILLUMINATING CATHETER SET 084120 manufactured by Cook Inc.
[106190829]
(b)(4). Pma/510(k) #: exempt. This was identified previously as a voluntary recalled device that the customer was notified and responded they didn't have any related product in stock. This report includes information known at this time.? A follow-up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[106190830]
It was reported that the bush ureteral illuminating catheter set began smoking and melted when the light source was connected. A section of the device did not remain inside the patient? S body. The patient did not require any additional procedures due to this occurrence.? According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-00972 |
| MDR Report Key | 7443450 |
| Date Received | 2018-04-19 |
| Date of Report | 2018-05-18 |
| Date of Event | 2018-03-15 |
| Date Mfgr Received | 2018-05-17 |
| Device Manufacturer Date | 2016-12-09 |
| Date Added to Maude | 2018-04-19 |
| 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 | MR. LARRY POOL |
| 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 |
| Removal Correction Number | Z-1870-2017 / RES 76927 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BUSH URETERAL ILLUMINATING CATHETER SET |
| Generic Name | FCS CATHETER, LIGHT, FIBEROPTIC, GLASS, URETERAL |
| Product Code | FCS |
| Date Received | 2018-04-19 |
| Catalog Number | 084120 |
| 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 INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-19 |