TEMNO ADJUSTABLE COAXIAL BIOPSY NDL
Received Nov 4, 2015 · Event occurred May 29, 2015
Report 9680904-2015-00068 · MDR key 5201794
Device
Generic name
Guide, Needle, Surgical
Manufacturer
CarefusionModel number
TEMNO ADJUSTABLE COAXIAL BIOPSY NDLProduct problems
- Break
Patient
Not reported
- No Information
Narrative
Additional Manufacturer Narrative
(B)(4). PER FACILITY MEDWATCH REPORTER; NO ADDITIONAL INFORMATION AVAILABLE. SHOULD FURTHER INFORMATION BECOME AVAILABLE, A FOLLOW UP EMDR WILL BE SUBMITTED.
Description of Event or Problem
CUSTOMER STATED VIA MAUDE REPORT: THE PT WAS HAVING A CAT SCAN GUIDED ASPIRATION OF THE LUMBAR SPINE AT LEVEL 1 WHEN THE NEEDLE BROKE INTO TWO PIECES. THE ONE PORTION WAS REMOVED BY THE INTERVENTIONAL RADIOLOGIST. THE OTHER HALF NEEDED TO BE REMOVED IN THE OPERATING ROOM. DIAGNOSIS OR REASON FOR USE: BIOPSY OF THE LUMBAR SPINE. ON 11/04/2015: FACILITY MEDWATCH REPORTERS RESPONSE- NO ADDITIONAL INFORMATION AVAILABLE.