FDA Adverse Event
Malfunction
Summary report: N
NAV 4.5MM TAP (CANNULATED)
MDR report key: 2881800
·
Received December 20, 2012
Report
- Report Number
- 1723170-2012-00756
- Event Type
- Malfunction
- Date Received
- December 20, 2012
- Date of Event
- November 26, 2012
- Report Date
- November 26, 2012
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
NO PATIENT WAS PRESENT AT THE TIME OF THE ALLEGED MALFUNCTION. RMA ISSUED. REPLACEMENT PART SHIPPED TO SITE (B)(4) 2012. MEDTRONIC INVESTIGATION FINDS THAT AS REPORTED, THE TAP IS CLOGGED WITH BONEY MATERIAL VISIBLE FROM THE TIP OF THE INSTRUMENT.
Description of Event or Problem · 1
A MEDTRONIC REPRESENTATIVE REPORTED A LEGACY TAP WAS CLOGGED. THIS WAS A DEMO INSTRUMENT DISCOVERED IN THE NAVIGATION ACCESS CENTER (NAC). SINCE THIS EVENT WAS REPORTED OUTSIDE THE OPERATING ROOM, NO PATIENT WAS PRESENT AT THE TIME OF THE ALLEGED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NAV 4.5MM TAP (CANNULATED) | NEUROLOGICAL STEREOTAXIC INSTRUMENT | HAW | MEDTRONIC NAVIGATION, INC. | 100724 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |