MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-11-07 for BUSH SINGLE LUMEN URETERAL ILLUMINATING CATHETER SET J-BICS-058020 manufactured by Cook Inc.
[5189687]
Doctor started surgery with cystoscopy for endometriosis. During the surgery doctor decided to do laparoscopy. Laparoscopy wasn't enough so they moved to laparotomy. After laparoscopy they took the illuminating catheter out and left it to lie on top of patient's leg. They also had to move the power source to make more room for the next procedure. They kept lights on the catheter and after a while they noticed a smell like something was burning. After surgery they noticed that the illuminating catheter was broken and had burned the covers under the catheter and also burned a small mark on the patients leg. The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
[12581706]
(b)(4). Event is still under investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2014-00611 |
| MDR Report Key | 4287597 |
| Report Source | 99 |
| Date Received | 2014-11-07 |
| Date of Report | 2014-10-23 |
| Date of Event | 2014-10-23 |
| Date Facility Aware | 2014-10-23 |
| Report Date | 2014-10-23 |
| Date Mfgr Received | 2014-10-24 |
| Device Manufacturer Date | 2014-05-01 |
| Date Added to Maude | 2014-12-02 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | RITA HARDEN, DIRECTOR |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BUSH SINGLE LUMEN URETERAL ILLUMINATING CATHETER SET |
| Generic Name | FCS CATHETER, LIGHT FIBEROPTIC, GLASS, URTERAL |
| Product Code | FCS |
| Date Received | 2014-11-07 |
| Model Number | NA |
| Catalog Number | J-BICS-058020 |
| Lot Number | 4992427 |
| ID Number | (01)00827002167377(17)17050(10 |
| Device Expiration Date | 2017-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-07 |