COMPUTER-ASSISTED SURGICAL DEVICE
This device is manufactured by MEDTECH SA.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2019 | Shipping Damage or Problem | 1 | Device |
| 2019 | Noise, Audible | 1 | Device |
| 2019 | No Display/Image | 1 | Device |
| 2019 | Mechanical Problem | 1 | Device |
| 2019 | Imprecision | 2 | Device |
| 2019 | Image Display Error/Artifact | 1 | Device |
| 2019 | Failure to Sense | 1 | Device |
| 2019 | Failure to Power Up | 1 | Device |
| 2019 | Connection Problem | 2 | Device |
| 2019 | Computer Software Problem | 13 | Device |
| 2019 | Break | 1 | Device |
| 2018 | Use of Device Problem | 1 | Device |
| 2018 | Unintended Collision | 1 | Device |
| 2018 | Unintended Arm Motion | 1 | Device |
| 2018 | Scratched Material | 1 | Device |
| 2018 | Positioning Failure | 1 | Device |
| 2018 | Patient Data Problem | 1 | Device |
| 2018 | No Display/Image | 1 | Device |
| 2018 | Misassembly by Users | 1 | Device |
| 2018 | Mechanics Altered | 1 | Device |
| 2018 | Mechanical Problem | 8 | Device |
| 2018 | Mechanical Jam | 3 | Device |
| 2018 | Loss of Data | 2 | Device |
| 2018 | Insufficient Information | 2 | Device |
| 2018 | Incorrect Software Programming Calculations | 5 | Device |
| 2018 | Inaccurate Delivery | 2 | Device |
| 2018 | Imprecision | 14 | Device |
| 2018 | Image Orientation Incorrect | 2 | Device |
| 2018 | Image Display Error/Artifact | 3 | Device |
| 2018 | Failure to Recalibrate | 1 | Device |
| 2018 | Failure to Power Up | 1 | Device |
| 2018 | Erratic or Intermittent Display | 1 | Device |
| 2018 | Entrapment of Device | 1 | Device |
| 2018 | Electrical Power Problem | 1 | Device |
| 2018 | Electrical /Electronic Property Problem | 1 | Device |
| 2018 | Display or Visual Feedback Problem | 2 | Device |
| 2018 | Disassembly | 1 | Device |
| 2018 | Device Stops Intermittently | 1 | Device |
| 2018 | Device Displays Incorrect Message | 1 | Device |
| 2018 | Device Damaged Prior to Use | 2 | Device |
| 2018 | Device Alarm System | 1 | Device |
| 2018 | Defective Component | 3 | Device |
| 2018 | Connection Problem | 2 | Device |
| 2018 | Computer Software Problem | 62 | Device |
| 2018 | Component Incompatible | 1 | Device |
| 2018 | Calibration Problem | 5 | Device |
| 2018 | Break | 4 | Device |
| 2018 | Bent | 2 | Device |
| 2018 | Appropriate Term/Code Not Available | 2 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2017 | Use of Device Problem | 2 | Device |
| 2017 | Unintended Movement | 3 | Device |
| 2017 | Unintended Collision | 16 | Device |
| 2017 | Unintended Arm Motion | 3 | Device |
| 2017 | Smoking | 1 | Device |
| 2017 | Operating System Becomes Nonfunctional | 1 | Device |
| 2017 | Off-Label Use | 2 | Device |
| 2017 | Noise, Audible | 1 | Device |
| 2017 | Moisture or Humidity Problem | 1 | Device |
| 2017 | Misconnection | 4 | Device |
| 2017 | Mechanical Problem | 17 | Device |
| 2017 | Mechanical Jam | 8 | Device |
| 2017 | Loss of Data | 3 | Device |
| 2017 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2017 | Imprecision | 20 | Device |
| 2017 | Fluid/Blood Leak | 1 | Device |
| 2017 | Failure to Calibrate | 2 | Device |
| 2017 | Entrapment of Device | 1 | Device |
| 2017 | Electrical /Electronic Property Problem | 2 | Device |
| 2017 | Disassembly | 9 | Device |
| 2017 | Difficult To Position | 1 | Device |
| 2017 | Device Stops Intermittently | 10 | Device |
| 2017 | Device Displays Incorrect Message | 6 | Device |
| 2017 | Device Difficult to Setup or Prepare | 8 | Device |
| 2017 | Detachment of Device or Device Component | 1 | Device |
| 2017 | Degraded | 1 | Device |
| 2017 | Data Problem | 1 | Device |
| 2017 | Computer Software Problem | 64 | Device |
| 2017 | Computer Operating System Problem | 5 | Device |
| 2017 | Component Missing | 3 | Device |
| 2017 | Communication or Transmission Problem | 2 | Device |
| 2017 | Calibration Problem | 5 | Device |
| 2017 | Bent | 1 | Device |
| 2017 | Application Program Problem: Parameter Calculation Error | 1 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2016 | Unintended Movement | 6 | Device |
| 2016 | Unintended Collision | 1 | Device |
| 2016 | Unintended Arm Motion | 2 | Device |
| 2016 | Mechanical Problem | 34 | Device |
| 2016 | Mechanical Jam | 5 | Device |
| 2016 | Imprecision | 20 | Device |
| 2016 | Failure To Adhere Or Bond | 1 | Device |
| 2016 | Difficult To Position | 2 | Device |
| 2016 | Device Stops Intermittently | 1 | Device |
| 2016 | Device Operational Issue | 2 | Device |
| 2016 | Device Operates Differently Than Expected | 1 | Device |
| 2016 | Device Handling Problem | 1 | Device |
| 2016 | Device Displays Incorrect Message | 14 | Device |
| 2016 | Degraded | 5 | Device |
| 2016 | Defective Component | 1 | Device |
| 2016 | Data Problem | 3 | Device |
| 2016 | Computer Software Problem | 2 | Device |
| 2016 | Computer Operating System Problem | 1 | Device |
| 2016 | Communication or Transmission Problem | 3 | Device |
| 2016 | Calibration Problem | 5 | Device |
| 2016 | Break | 7 | Device |
| 2015 | Unintended Collision | 3 | Device |
| 2015 | Positioning Problem | 1 | Device |
| 2015 | Mechanical Problem | 63 | Device |
| 2015 | Mechanical Jam | 9 | Device |
| 2015 | Manufacturing, Packaging or Shipping Problem | 2 | Device |
| 2015 | Loss of or Failure to Bond | 2 | Device |
| 2015 | Imprecision | 16 | Device |
| 2015 | Image Display Error/Artifact | 1 | Device |
| 2015 | Device Operational Issue | 4 | Device |
| 2015 | Device Maintenance Issue | 1 | Device |
| 2015 | Device Displays Incorrect Message | 1 | Device |
| 2015 | Degraded | 4 | Device |
| 2015 | Defective Component | 3 | Device |
| 2015 | Date/Time-Related Software Problem | 1 | Device |
| 2015 | Data Problem | 5 | Device |
| 2015 | Computer Software Problem | 5 | Device |
| 2015 | Computer Operating System Problem | 4 | Device |
| 2015 | Component Missing | 3 | Device |
| 2015 | Communication or Transmission Problem | 4 | Device |
| 2015 | Calibration Problem | 11 | Device |
| 2015 | Break | 9 | Device |
| 2014 | Mechanical Problem | 20 | Device |
| 2014 | Mechanical Jam | 1 | Device |
| 2014 | Manufacturing, Packaging or Shipping Problem | 1 | Device |
| 2014 | Loss of or Failure to Bond | 1 | Device |
| 2014 | Imprecision | 6 | Device |
| 2014 | Image Display Error/Artifact | 1 | Device |
| 2014 | Failure to Calibrate | 1 | Device |
| 2014 | Device Operational Issue | 6 | Device |
| 2014 | Device Displays Incorrect Message | 1 | Device |
| 2014 | Detachment of Device or Device Component | 1 | Device |
| 2014 | Degraded | 4 | Device |
| 2014 | Defective Component | 5 | Device |
| 2014 | Data Problem | 1 | Device |
| 2014 | Computer Software Problem | 2 | Device |
| 2014 | Computer Operating System Problem | 1 | Device |
| 2014 | Component Missing | 3 | Device |
| 2014 | Communication or Transmission Problem | 4 | Device |
| 2014 | Calibration Problem | 17 | Device |
| 2014 | Break | 3 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 1 | Device |