MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2017-12-28 for FLEXOR URETERAL ACCESS SHEATH AND DILATORS FUS-120035 manufactured by Cook Inc.
[96125004]
(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
[96125005]
It was reported that during a ureteroscopy procedure that the access sheath was used to gain access into the ureter for dilation. The scope was then placed inside the access sheath and a piece of plastic from inside the access sheath came loose. The access sheath was removed with the plastic piece and another sheath was used to complete the procedure. No known adverse event was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2017-04592 |
| MDR Report Key | 7151714 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-12-28 |
| Date of Report | 2018-03-26 |
| Date of Event | 2017-12-07 |
| Date Mfgr Received | 2018-02-26 |
| Device Manufacturer Date | 2017-10-24 |
| Date Added to Maude | 2017-12-28 |
| 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 | 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 | 2017-12-28 |
| Catalog Number | FUS-120035 |
| 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 | 2017-12-28 |