FDA Adverse Event
Malfunction
Summary report: N
NAVIGATION SYSTEM II - CART
MDR report key: 3072793
·
Received April 23, 2013
Report
- Report Number
- 0001811755-2013-00860
- Event Type
- Malfunction
- Date Received
- April 23, 2013
- Date of Event
- March 26, 2013
- Report Date
- March 26, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- HAW
- PMA / PMN Number
- K993239
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE EVENT WITHOUT AN EVALUATION OF THE DEVICE. ADDITIONAL INFORMATION WILL BE SUBMITTED WHEN THE DEVICE IS RECEIVED AND EVALUATED. (B)(4).
Additional Manufacturer Narrative · 1
NO FAILURE WAS FOUND WITH THE NAVIGATION CART: THE MAIN POWER CABLE THAT WAS RETURNED WITH THE NAVIGATION CART WAS SLICED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE NAVIGATION SYSTEM II - CART CABLE HAD A SPLIT IN IT WITH WIRES EXPOSED. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE NAVIGATION SYSTEM II - CART CABLE HAD A SPLIT IN IT WITH WIRES EXPOSED. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 174874 | NAVIGATION SYSTEM II - CART | STEREOTAXIC INSTRUMENT | HAW | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |