Hospitals in Denmark lifted a hiatus on use of Intuitive Surgical‘s (NSDQ:ISRG) da Vinci robot surgery system after an external investigation resolved sterilization concerns, according to the Danish Health & Medicines Authority.
Odense University Hospital, Denmark’s largest hospital, informed the DHMA late last monht that it planned to temporarily discontinue da Vinci robot surgical procedures because "the hospital had identified potential problems with the quality of the associated surgical instruments."
No adverse events were linked to any da Vinci robot procedures, but Danish investigators noted "surface irregularities, which raised doubt as to whether the instruments could be sterilized," according to the DHMA report.
The agency relayed those concerns to other institutions with in-house da Vinci robot systems. As a preventive measure, the centers temporarily discontinued their da Vinci robot procedures and offered patients traditional surgery instead.
"Intuitive takes any concerns regarding the quality of our products very seriously," spokeswoman Angela Wonson told MassDevice.com today. "Upon being informed of our Danish customers’ concern, Intuitive Surgical quickly launched its own investigation using advanced analytical tools and inspecting a variety of instruments from representative locations. Intuitive Surgical scientists, working in collaboration with Danish customers and in communication with Danish Regulatory Authorities, were able to confirm that da Vinci instruments can be safely cleaned and sterilized and meet all applicable regulatory standards, resulting in a prompt resumption of da Vinci surgery in Denmark."
On July 10 all 5 hospitals resumed procedures with the da Vinci robot system after an external investigation provided reassurance and Intuitive Surgical offered its guarantee that da Vinci procedures could be conducted safely for patients, according to the report.
The centers also updated their action plans with consistent instructions on how to use and clean the device in accordance with Danish regulatory guidelines.
"The hospitals now have sufficient documentation to resume surgery with the da Vinci surgical system," according to the DHMA release. "The decision was based on the conclusion of an external investigation and further documentation provided by the manufacturer on the sterilization of the associated reusable instruments of the system."
The machines were down at a handful of centers for about 2 weeks; the loss to revenue wasn’t material, Wonson told us.