MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-19 for BUSH URETERAL ILLUMINATING CATHETER SET manufactured by Cook Incorporated.
[65245254]
Patient Sequence No: 1, Text Type: N, H10
[65245255]
During a surgical procedure, a ureteral laminating stent was plugged into light source and after 15 to 20 seconds after being plugged in, staff noted smoke coming out of the light source hole above where the stent was plugged into. Surgeon stated unable to see stent lighted and surgeon started to unplug it. After turning off, smoke came out of both holes where it was unplugged. Staff person reported visually saw bright red center at end of stent where it was plugged into light source. Biomed noted event as "unit smoked when user connected ureteral illuminating catheter set. Cook medical; lot #6998468; ref # (b)(4). Tech was able to duplicate the problem when he connected the catheter to the light source. Unit worked ok with other head set. Contacted manufacturer and reported the problem and a representative picked up the catheter for an investigation. In follow up to the investigation, cook reported that there was no indication that a design or process related failure mode contributed to the event a definitive root cause could not be established.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6263152 |
| MDR Report Key | 6263152 |
| Date Received | 2017-01-19 |
| Date of Report | 2017-01-18 |
| Date of Event | 2016-11-11 |
| Report Date | 2017-01-18 |
| Date Reported to FDA | 2017-01-18 |
| Date Reported to Mfgr | 2017-01-18 |
| Date Added to Maude | 2017-01-19 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BUSH URETERAL ILLUMINATING CATHETER SET |
| Generic Name | LIGHT, CATHETER, FIBEROPTIC, GLASS, URETERAL |
| Product Code | FCS |
| Date Received | 2017-01-19 |
| Returned To Mfg | 2016-11-22 |
| Lot Number | 6998468 |
| Operator | NURSE |
| Device Availability | R |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | COOK INCORPORATED |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-19 |