FDA Adverse Event
Injury
Summary report: N
FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS
MDR report key: 3800230
·
Received April 30, 2014
Report
- Report Number
- 1820334-2014-00180
- Event Type
- Injury
- Date Received
- April 30, 2014
- Date of Event
- April 3, 2014
- Report Date
- April 3, 2014
- Manufacturer
- COOK UROLOGICAL INC.
- Product Code
- FED
- PMA / PMN Number
- K961904
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVENT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
A (B)(6) MALE PATIENT UNDERWENT FLEX URS KIDNEY STONE PROCEDURE WITH WOLF COBRA AND ANOTHER MANUFACTURER'S (TELEFLEX) WIRE GUIDE ON (B)(6) 2014. A PIECE OF WIRE GUIDE BECAME STUCK IN URETER. THEY CAUGHT THE END OF THE WIRE OUT O THE KIDNEY WITH AN EXTRACTOR. PER THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOT ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 258990 | FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS | ENDOSCOPIC ACCESS OVERTUBE/GASTROENTEROLOGY-UROLOGY | FED | COOK UROLOGICAL INC. | NA | U2433572 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Required Intervention |