Jun 2021 : FCA_DTG_Intuitive Surgical ISIFA2021-01-C : da Vinci® S/Si Harmonic Ace Reprocessing Instructions For Use (IFU)
FCA_DTG_Intuitive Surgical ISIFA2021-01-C : da Vinci® S/Si Harmonic Ace Reprocessing Instructions For Use (IFU)
Affected Medical Device :
Da Vinci S Surgical System, Endoscopic Instrument Control System,
Model IS2000Da Vinci SiSurgical System, Endoscopic Instrument Control System, Model IS3000
MDA Reference Number : MDA/FCA/2021-P086
MDA Registration Number :
GC67840390317
GC74543334017
Decription : the number of uses and number of reprocessing cycles for the da Vinci S/Si Harmonic ACE Reusable Instrument Housings (5mm PN: 420274-XX /8mm PN: 420275-XX) are incorrectly listed as “N/A” in the S/Si reprocessing IFU appendices (see affected IFU part numbers list below)
Local Establishment Contact Detail :
Tan Li Fang
Regulatory Affairs Associate
Unit 27-8, Menara One Mont Kiara,Jalan Kiara, Mont Kiara, 50480 Kuala Lumpur, Malaysia.
Email : [email protected]
