FDA Adverse Event
Malfunction
Summary report: N
ACUCISE ENDOURETEROTOMY CATHETER KIT
MDR report key: 1532082
·
Received November 3, 2009
Report
- Report Number
- 1532082
- Event Type
- Malfunction
- Date Received
- November 3, 2009
- Date of Event
- November 3, 2009
- Report Date
- November 3, 2009
- Manufacturer
- APPLIED MEDICAL RESOURCES CORP
- Product Code
- DQX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- DE, US
Narratives
Description of Event or Problem · 1
ACUCISE ENDOURETEROTOMY CATHETER KIT ORDERED FOR MD'S PROCEDURE, HOWEVER WHEN THE PACKAGE WAS OPENED DURING THE PROCEDURE, THE GUIDEWIRE HAD A DEFECTIVE STOPCOCK. A SEPARATE GUIDEWIRE HAD TO BE USED FOR THE COMPLETION OF THIS PROCEDURE. THIS ITEM WAS PART OF A KIT SUPPLIED BY APPLIED MEDICAL, REFERENCE NUMBER B1005, LOT NUMBER 1092430.
Description of Event or Problem · 1
ACUCISE ENDOURETEROTOMY CATHETER KIT ORDERED FOR MD'S PROCEDURE, HOWEVER WHEN THE PACKAGE WAS OPENED DURING THE PROCEDURE, THE GUIDEWIRE HAD A DEFECTIVE STOPCOCK. A SEPARATE GUIDEWIRE HAD TO BE USED FOR THE COMPLETION OF THIS PROCEDURE. THIS ITEM WAS PART OF A KIT SUPPLIED BY APPLIED MEDICAL, REFERENCE NUMBER B1005, LOT NUMBER 1092430.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACUCISE ENDOURETEROTOMY CATHETER KIT | GUIDEWIRE (STOPCOCK) | DQX | APPLIED MEDICAL RESOURCES CORP | CE-0843 | 1092430 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |