MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other, report with the FDA on 2016-11-14 for BUSH URETERAL ILLUMINATING CATHETER SET N/A 084120 manufactured by Cook Inc.
[59861447]
(b)(4). The event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[59861448]
Information was provided that the bush ureteral illuminating catheter was inside the patient when it started melting about mid-section. It was reported that the cable pulled apart like taffy. The device was removed and the patient was checked for injuries, no injuries were noted. No other information was available at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
[69458998]
Concomitant medical products: light source: manufacturer - sun optix , model 300. (b)(4). The event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[69458999]
Information was provided that the bush ureteral illuminating catheter was inside the patient when it started melting about mid-section. It was reported that the cable pulled apart like taffy. The device was removed and the patient was checked for injuries, no injuries were noted. No other information was available at the time of this report. Additional information was received and the event was clarified: customer reported that the device overheated and melted during a procedure to explant a patients' colon. Overheated and melted section was related to the connector and black cord of the device before the actual lighted stents; no portion of the overheated device was within the patient. The device was in use for a the entire procedure and the light source intensity was "very likely turned all the way up. " the light source was a sun optes 400. The device was in use "not long' before the overheating was noted. No patient injury was reported, however, an unconfirmed report from the customer indicated that a staff member was burned while unplugging the device. No further information about the alleged burn or medical attention needed to address the alleged burn was provided. The procedure was completed without illumination. The instructions for use that accompany each device states under the precautions section that " the anodized aluminum plug conducts heat. Allow the plug to cool down prior to attempting to unplug. " the instructions for use also state under the instructions for use section that: " note: this catheter will not transmit thermal energy along its light fibers to patient tissue. Any excessive thermal damage from the light source will manifest at the catheter/light plug junction and will not be transmitted along the catheter length. " "note: high-energy light sources such as xenon may cause overheating of the anodized aluminum plug. An adapter (available from most light source manufacturers) will ensure product safety and functionality. " "note: start illumination with the light source at the lowest setting, as many light sources produce thermal energy at varying temperatures. This will limit the possibility of thermal damage at the catheter/light plug junction. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2016-01282 |
| MDR Report Key | 6100349 |
| Report Source | COMPANY REPRESENTATIVE,OTHER, |
| Date Received | 2016-11-14 |
| Date of Report | 2017-07-13 |
| Date of Event | 2016-10-17 |
| Date Mfgr Received | 2017-06-29 |
| Device Manufacturer Date | 2015-04-13 |
| Date Added to Maude | 2016-11-14 |
| 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 |
| 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 | 2016-11-14 |
| Model Number | N/A |
| Catalog Number | 084120 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-11-14 |