MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-01-13 for BUSH URETERAL ILLUMINATING CATHETER SET N/A 084120 manufactured by Cook Inc.
[65093957]
(b)(4). Investigation summary: one used bush illuminating catheter was returned. The returned device was visually inspected and found melted and separated at the distal end of the junction of the black protective sleeve and the clear optical fiber. Cook inc. Has received similar reports of this device melting at this junction. According to our previous investigations, the most likely cause is overheating due to a high light source setting over an extended period of time. Cook inc. Has received adverse event reports related to this issue. The ifu (t_bdlslc_rev0) provides the following 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. It is inadvisable to use any light source at its highest setting, unless the light source? S actual thermal energy output is known. " although requested, cook inc. Was not able to determine the light source used during this reported event or the setting for that light source. A review of the device history record did not indicate any manufacturing anomalies. During manufacturing this device is illuminated and inspected using a storz light source at a controlled setting. The ifu also states,? A variety of light sources may be used. The supplied plug fits a standard circon- a. C. M. I. Light sources (b)(4), (b)(4) and (b)(4)-1. Storz, olympus and other light sources may be used. High energy light sources, such as xenon, may cause overheating of the anodized aluminum plug. An appropriate adapter (available from most light source manufacturers) will ensure product safety and functionality. For storz xenon light source, use "turret adapter 487uo. "" conclusion: the most likely cause of this reported event is overheating due to a high light source setting over an extended period of time. A stop ship has been executed to prevent further distribution until this issue is better understood. A capa has been opened to investigate this issue further ((b)(4)).
Patient Sequence No: 1, Text Type: N, H10
[65093958]
Prior to a procedure, the bush ureteral illuminating catheter burnt where the catheter connects to the light source cord. This observation was made prior to patient contact and there was no impact to a patient or end user.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2017-00117 |
| MDR Report Key | 6250645 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-01-13 |
| Date of Report | 2017-07-13 |
| Date Mfgr Received | 2017-06-29 |
| Date Added to Maude | 2017-01-13 |
| 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 | 2017-01-13 |
| 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 | 2017-01-13 |