FDA Adverse Event
Malfunction
Summary report: N
UROPASS URETERAL ACCESS SHEATH, 38CM, BOX OF 5UR
MDR report key: 1365177
·
Received March 6, 2009
Report
- Report Number
- 2183680-2009-00011
- Event Type
- Malfunction
- Date Received
- March 6, 2009
- Date of Event
- February 16, 2009
- Report Date
- March 6, 2009
- Manufacturer
- GYRUS MEDICAL INC.
- Product Code
- KNY
- PMA / PMN Number
- K051593
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFORMATION BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION, AND UPDATE THE AGENCY ACCORDINGLY.
Description of Event or Problem · 1
INCIDENT WAS REPORTED WITH OUT DUR-D 61238BX ACCESS SHEATH AND 35BX GUIDEWIRE. THE SURGEON WAS USING THIS EQUIPMENT AND PERFORATED A PT'S URETER. THE PT WAS SUSPECTED OF HAVING CANCER IN THE KIDNEY. AS A RESULT OF THE PERFORATION, THE SURGEON HAD TO OPEN THE PT TO REPAIR THE URETER. ONCE HE OPENED, HE DISCOVERED THE PT HAD SEVERE CANCER, AND REMOVED HIS KIDNEY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UROPASS URETERAL ACCESS SHEATH, 38CM, BOX OF 5UR | UROPASS URETERAL ACCESS SHEATH, 38CM,BOX | KNY | GYRUS MEDICAL INC. | 61238BX | MBLD690 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 91 YR | Required Intervention |