MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-08-21 for BUSH URETERAL ILLUMINATING CATHETER SET 084120 manufactured by Cook Urological, Inc..
[2796583]
The tip that connects to the clear part that goes inside the patient melted. The patient was burnt about 1 cm. Medicated vaseline to treat burn left mid thigh. Medicated vaseline to treat burn left mid thigh.
Patient Sequence No: 1, Text Type: D, B5
[10031174]
The device consists of two bare fiber optic light fibers that are used to illuminate the patient's ureters during laparoscopic or open surgical procedures. The light fibers, which can be removed and reattached by the user, are connected via ptfe fittings to two jacketed fiber optic light fibers that are fixed in an aluminum connector. The aluminum connector attaches to various, commercially-available light sources. The used product was returned for evaluation. The ptfe connector located at the distal end of one of the two jacketed fibers was missing. In addition, approximately 2 mm of the jacketing material at the distal end of that fiber had the appearance of having been melted by an unidentifiable source. The aluminum connector and the proximal ends of the jacketed fibers were intact and did not show any signs of overheating or melting. The second jacketed fiber and ptfe fitting showed no signs of overheating or melting. In addition, both of the removable distal fibers (the bare fibers) were returned and did not have any appearance of overheating or melting. The instructions for use inform users that depending upon the type of light source used and the settings, the aluminum connector can heat up and cause thermal damage at the junction of the connector and the jacketed fibers. The instructions further instruct users to start the light source at the lowest settings, to avoid the highest settings, and to use an appropriate adapter with xenon light sources. Cook is unable at this time to recreate the user's experience or to determine the cause of the failure. It is unlikely, however, that the damage to the distal end of the jacketed fiber was caused by heat transmission from the light source through the jacketed fiber, as the fiber material does not readily conduct heat, only one of the two jacketed fibers was damaged, and there was no damage to the plug or the proximal ends of the jacketed fibers. We have requested additional information from the user facility regarding the type of light source used and the heat settings. Any additional information received by our facility will be forwarded to the agency.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825146-2012-00017 |
| MDR Report Key | 2715525 |
| Report Source | 05,06 |
| Date Received | 2012-08-21 |
| Date of Report | 2012-08-16 |
| Date of Event | 2012-05-25 |
| Date Facility Aware | 2012-05-25 |
| Report Date | 2012-07-19 |
| Date Reported to Mfgr | 2012-07-19 |
| Date Mfgr Received | 2012-07-19 |
| Date Added to Maude | 2012-08-28 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRIS KILANDER |
| Manufacturer Street | 1100 WEST MORGAN |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal | 47460 |
| Manufacturer Phone | 8128294891 |
| 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 | 2012-08-21 |
| Returned To Mfg | 2012-08-08 |
| Catalog Number | 084120 |
| Lot Number | UNKNOWN |
| 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 UROLOGICAL, INC. |
| Manufacturer Address | SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-08-21 |