MARYLAND BIPOLAR FORCEPS INSTRUMENT

ENDOSCOPIC ELECTROSURGICAL INSTRUMENT

This device is manufactured by INTUITIVE SURGICAL.

The following problems were reported about this device:

Year Description Events/year Type
2021 Material Integrity Problem 1 Device
2019 Break 2 Device
2018 Material Protrusion/Extrusion 1 Device
2018 Device Operates Differently Than Expected 1 Device
2017 Device Operates Differently Than Expected 1 Device
2017 Device Issue 1 Device
2017 Detachment Of Device Component 3 Device
2017 Defective Component 1 Device
2017 Break 6 Device
2016 Self-Activation or Keying 1 Device
2016 Flaked 1 Device
2016 Break 4 Device
2015 Device Inoperable 1 Device
2015 Cut In Material 1 Device
2015 Break 9 Device
2014 Unintended Movement 2 Device
2014 Torn Material 6 Device
2014 Thermal Decomposition of Device 2 Device
2014 Stretched 1 Device
2014 Sticking 3 Device
2014 Sparking 4 Device
2014 Smoking 1 Device
2014 Scratched Material 1 Device
2014 Positioning Problem 7 Device
2014 Melted 2 Device
2014 Material Twisted/Bent 1 Device
2014 Material Protrusion/Extrusion 5 Device
2014 Material Frayed 41 Device
2014 Malposition of Device 5 Device
2014 Loss of Power 1 Device
2014 Loose or Intermittent Connection 15 Device
2014 Looping 1 Device
2014 Lack of Maintenance Documentation or Guidelines 1 Device
2014 Kinked 2 Device
2014 Insufficient Information 2 Device
2014 Improper or Incorrect Procedure or Method 2 Device
2014 Human-Device Interface Problem 1 Device
2014 Failure to Sense 1 Device
2014 Failure to Power Up 1 Device
2014 Failure to Align 28 Device
2014 Failure to Advance 1 Device
2014 Difficult to Open or Close 13 Device
2014 Difficult to Insert 1 Device
2014 Difficult to Advance 2 Device
2014 Device Stops Intermittently 1 Device
2014 Device Slipped 4 Device
2014 Device Sensing Problem 6 Device
2014 Device Operates Differently Than Expected 28 Device
2014 Device Inoperable 18 Device
2014 Device Expiration Issue 1 Device
2014 Detachment of Device or Device Component 1 Device
2014 Detachment Of Device Component 10 Device
2014 Defective Component 1 Device
2014 Cut In Material 3 Device
2014 Crack 3 Device
2014 Component Missing 2 Device
2014 Component Falling 2 Device
2014 Break 129 Device
2014 Bent 6 Device
2014 Arcing 3 Device
2014 Adverse Event Without Identified Device or Use Problem 1 Device
2013 Torn Material 2 Device
2013 Sticking 1 Device
2013 Sparking 2 Device
2013 Material Protrusion/Extrusion 2 Device
2013 Material Frayed 2 Device
2013 Fire 1 Device
2013 Failure to Align 5 Device
2013 Disconnection 1 Device
2013 Device Slipped 2 Device
2013 Device Sensing Problem 1 Device
2013 Device Operates Differently Than Expected 7 Device
2013 Device Inoperable 1 Device
2013 Device Displays Incorrect Message 1 Device
2013 Detachment Of Device Component 2 Device
2013 Defective Device 1 Device
2013 Component Missing 1 Device
2013 Break 14 Device
2013 Bent 1 Device