Robotic surgery using the da Vinci Surgical System will resume Tuesday 10 July in Denmark, after having been halted for the past two weeks. The decision to resume surgery with the da Vinci Surgical System was taken by the five national robot centres based on an independent investigation and further documentation from the manufacturer Intuitive Surgical.
The hospitals now have sufficient documentation to resume surgery with the da Vinci Surgical System. The decision was based on the conclusion of an external investigation and further documentation provided by the manufacturer on the sterilisation of the associated reusable instruments of the system.
Moreover, the national robot centres will update their action plans which ensure harmonised instructions on how to use and clean the surgical instruments of the systems in Denmark.
Surgery with the da Vinci Surgical System was preventively discontinued in Denmark after an investigation had identified surface irregularities, which raised doubt as to whether the instruments could be sterilised.
There have been no reports of adverse reactions as a consequence of the use of the da Vinci Surgical System, at any of the Danish hospitals.
All affected hospitals and the Danish Health and Medicines Authority contacted the manufacturer to obtain a guarantee that surgical procedures using the da Vinci Surgical System can be conducted safely for the patients. The manufacturer has provided this guarantee. When the da Vinci Surgical System was not in use, patients were offered traditional surgery as an alternative to robotic surgery.
Course of events
On 20 June, Odense University Hospital in Denmark informed the Danish Health and Medicines Authority that the hospital was temporarily discontinuing surgical procedures with the da Vinci Surgical System, because the hospital had identified potential problems with the quality of the associated surgical instruments.
The Danish Health and Medicines Authority contacted all Danish hospitals using the da Vinci Surgical System. Herlev Hospital informed the Danish Health and Medicines Authority about the identification of potential problems with the quality of the associated surgical instruments. As a result, all hospitals in Denmark who use the da Vinci Surgical System preventively discontinued surgical procedures with the system, awaiting more information about the quality of the surgical instruments. In addition to Odense University Hospital and Herlev Hospital, this included Aarhus University Hospital, Aalborg Hospital and Copenhagen University Hospital.
About the da Vinci Surgical System
The da Vinci Surgical System is an extremely sensitive instrument, which is operated by the surgeon by means of a joystick. The instrument enables surgeons to operate through tiny incisions on small organs in very confined spaces of the body. In Denmark, the da Vinci Surgical System is predominantly used in gynaecological and urological surgery.
Chief Medical Officer, Morten Noreng, tel: +45 6093 3699
Aarhus University Hospital
Center Director, Lisbeth Kallestrup, tel: +45 7846 1640 /+45 4046 8010
Odense University Hospital
Chief Executive Officer, Peter Fosgrau, +45 2629 0798
Copenhagen University Hospital
Head of Department, Per Bagi, +45 3545 2743
Deputy Chief Executive Officer, Gitte Fangel, +45 3045 4139
Danish Health and Medicines Authority
Head of Unit, Ellen Jespersen, +45 4488 9790