MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-11-08 for FLEXOR URETERAL ACCESS SHEATH AND DILATORS FUS-120045 manufactured by Cook Inc.
[91323105]
(b)(4). The event is currently under investigation. A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[91323106]
The area representative reported that a male patient underwent a ureteroscopy and laser lithotripsy, and basket extraction of kidney stones. During the procedure, the flexor ureteral access sheath and dilators were utilized. As reported, a shred of plastic from a 45cm ureteric access sheath was noted in the patient? S ureter during the surgery and it was retrieved. No unintended portion of any of these devices was left in the patient? S body. There were no additional procedures required due to the reported issues. There has been no adverse effect to the patient resulting of the reported device issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2017-03915 |
| MDR Report Key | 7009188 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-11-08 |
| Date of Report | 2018-02-15 |
| Date of Event | 2017-10-27 |
| Date Mfgr Received | 2018-01-25 |
| Date Added to Maude | 2017-11-08 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXOR URETERAL ACCESS SHEATH AND DILATORS |
| Generic Name | KOE DILATOR, URETHRAL |
| Product Code | KOE |
| Date Received | 2017-11-08 |
| Catalog Number | FUS-120045 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 1. Required No Informationntervention | 2017-11-08 |