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 2019-02-22 for FLEXOR URETERAL ACCESS SHEATH AND DILATORS G19168 FUS-120035 manufactured by Cook Inc.
[137561104]
(b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[137561225]
In preparation for a flexible ureteroscopy the access sheath was flushed with sterile water which activates the hydrophilic coating. When the sterile water was flushed through the sheath, the sterile water appeared to have debris in it and the sterile water was cloudy in appearance. Another sheath was opened with no further issues. There was no patient contact with the sheath in question.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-00494 |
| MDR Report Key | 8363148 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-22 |
| Date of Report | 2019-03-22 |
| Date of Event | 2019-02-18 |
| Date Mfgr Received | 2019-03-14 |
| Device Manufacturer Date | 2018-05-03 |
| Date Added to Maude | 2019-02-22 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| 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 | 2019-02-22 |
| Returned To Mfg | 2019-03-06 |
| Model Number | G19168 |
| Catalog Number | FUS-120035 |
| Lot Number | 8860824 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2019-02-22 |