FA1204 9733763 & S9735585 Biopsy Depth Gauge Cycle View Inaccuracy Phase 1

 

 

Affected Medical Device : 

SOFTWARE 9733763 SYNERGY CRANIAL S7
SOFTWARE 9735585 STEALTHSTATION CRANIAL

 

MDA Reference Number : MDA/FCA/2021-P167

 

MDA Registration Number : GD86373862018

 

Description :

Medtronic has identified an anomaly with the StealthStation™ System Cranial software Biopsy Depth Gauge graphical display which presents during navigation in a Cranial Biopsy Procedure. When this anomaly presents, the software enters a state where the Biopsy Depth Gauge is no longer synchronized with the navigational information displayed on the screen. This causes the position of the biopsy needle to be displayed inaccurately.

 

Local Establishment Contact Detail :

Athirah Abu Bakar
Regulatory Affairs Contingent
Medtronic
B-23-01, The Ascent, Paradigm
No. 1, Jalan SS7/26A,
47301 Petaling Jaya,
Selangor Darul Ehsan, Malaysia
Office +603-78838034 | Fax +603-78860474/4702

 

Email : athirah.abu.bakar@medtronic.com