Medtronic files safety warning in UK over robotic system

Medtronic warned healthcare providers that a piece of its Mazor X surgical system may release unexpectedly from the operating table, according to Medtech Dive

The Mazor X system is a device that precisely positions surgical instruments or implants during spine and brain surgery. 

Medtronic said the detachment issue is likely due to slight air leakage into the device's pneumatic system and could result in the surgical system falling onto a patient, which could cause blunt injury leading to hemorrhage, hematoma, bleeding or fractures, according to Medtech Dive

In an urgent field safety notice sent to healthcare providers in December, Medtronic said that it had received seven complaints of the detachment issue as of Nov. 13, though none involved patient injuries. 

The company offered modified instructions to safely set up the system to avoid the hardware detachment issue and said it is working on a permanent solution to correct the issue. 

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