AUTOMATED TISSUE PROCESSOR
This device is manufactured by LEICA BIOSYSTEMS MELBOURNE PTY.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Insufficient Information | 2 | Patient |
| 2024 | Improper or Incorrect Procedure or Method | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2023 | Insufficient Information | 2 | Patient |
| 2023 | Loose or Intermittent Connection | 2 | Device |
| 2023 | Improper or Incorrect Procedure or Method | 4 | Device |
| 2022 | Insufficient Information | 1 | Patient |
| 2022 | Improper or Incorrect Procedure or Method | 100 | Device |
| 2019 | Improper or Incorrect Procedure or Method | 30 | Device |
| 2019 | Application Program Problem: Parameter Calculation Error | 2 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2018 | Use of Device Problem | 1 | Device |
| 2018 | Programming Issue | 2 | Device |
| 2018 | Insufficient Information | 2 | Device |
| 2018 | Installation-Related Problem | 1 | Device |
| 2018 | Improper or Incorrect Procedure or Method | 49 | Device |
| 2018 | Device Operates Differently Than Expected | 2 | Device |
| 2018 | Device Issue | 2 | Device |
| 2018 | Device Displays Incorrect Message | 4 | Device |
| 2018 | Application Program Problem: Parameter Calculation Error | 2 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 85 | Device |
| 2017 | Use of Device Problem | 4 | Device |
| 2017 | Missing Value Reason | 2 | Device |
| 2017 | Mechanical Problem | 1 | Device |
| 2017 | Leak/Splash | 1 | Device |
| 2017 | Insufficient Information | 3 | Device |
| 2017 | Incorrect Or Inadequate Test Results | 1 | Device |
| 2017 | Improper or Incorrect Procedure or Method | 6 | Device |
| 2017 | Difficult to Remove | 1 | Device |
| 2017 | Device Operational Issue | 2 | Device |
| 2017 | Device Operates Differently Than Expected | 4 | Device |
| 2017 | Device Inoperable | 1 | Device |
| 2017 | Device Displays Incorrect Message | 1 | Device |
| 2017 | Appropriate Term/Code Not Available | 1 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 96 | Device |
| 2016 | Use of Device Problem | 17 | Device |
| 2016 | Therapeutic or Diagnostic Output Failure | 1 | Device |
| 2016 | Product Quality Problem | 8 | Device |
| 2016 | Physical Property Issue | 1 | Device |
| 2016 | Output below Specifications | 1 | Device |
| 2016 | No Apparent Adverse Event | 1 | Device |
| 2016 | Insufficient Information | 2 | Device |
| 2016 | Improper or Incorrect Procedure or Method | 19 | Device |
| 2016 | Improper Device Output | 1 | Device |
| 2016 | Fluid/Blood Leak | 2 | Device |
| 2016 | Failure to Cut | 1 | Device |
| 2016 | Device Operational Issue | 1 | Device |
| 2016 | Device Operates Differently Than Expected | 13 | Device |
| 2016 | Device Maintenance Issue | 2 | Device |
| 2016 | Device Handling Problem | 1 | Device |
| 2016 | Device Emits Odor | 1 | Device |
| 2016 | Device Displays Incorrect Message | 4 | Device |
| 2016 | Contamination of Device Ingredient or Reagent | 1 | Device |
| 2016 | Computer Operating System Problem | 1 | Device |
| 2016 | Component Falling | 2 | Device |
| 2016 | Break | 2 | Device |
| 2016 | Appropriate Term/Code Not Available | 13 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 83 | Device |
| 2015 | Sticking | 1 | Device |
| 2015 | Mechanical Problem | 1 | Device |
| 2015 | Material Integrity Problem | 1 | Device |
| 2015 | Improper or Incorrect Procedure or Method | 16 | Device |
| 2015 | Difficult to Open or Close | 1 | Device |
| 2015 | Device Reprocessing Problem | 1 | Device |
| 2015 | Device Operates Differently Than Expected | 8 | Device |
| 2015 | Device Displays Incorrect Message | 8 | Device |
| 2015 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2014 | Pressure Problem | 1 | Device |
| 2014 | Output below Specifications | 1 | Device |
| 2014 | Insufficient Information | 2 | Device |
| 2014 | Improper or Incorrect Procedure or Method | 11 | Device |
| 2014 | Fluid/Blood Leak | 1 | Device |
| 2014 | Failure to Sense | 1 | Device |
| 2014 | Failure to Obtain Sample | 3 | Device |
| 2014 | Device Operates Differently Than Expected | 5 | Device |
| 2014 | Appropriate Term/Code Not Available | 3 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 9 | Device |
| 2013 | Device Operates Differently Than Expected | 1 | Device |
| 2013 | Adverse Event Without Identified Device or Use Problem | 1 | Device |