INSTRUMENT, ULTRASONIC SURGICAL
This device is manufactured by COVIDIEN, COVIDIEN FORMERLY VALLEYLAB A DIVISION OF TYCO HEALTHCARE, COVIDIEN LP, MEDTRONIC.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Insufficient Information | 3 | Patient |
| 2024 | Self-Activation or Keying | 3 | Device |
| 2024 | Material Separation | 1 | Device |
| 2024 | Insufficient Information | 1 | Device |
| 2024 | Failure to Fire | 8 | Device |
| 2024 | Difficult to Open or Close | 1 | Device |
| 2024 | Difficult or Delayed Activation | 1 | Device |
| 2024 | Device Difficult to Setup or Prepare | 2 | Device |
| 2024 | Detachment of Device or Device Component | 13 | Device |
| 2024 | Defective Device | 1 | Device |
| 2023 | Laceration(s) | 1 | Patient |
| 2023 | Burn(s) | 1 | Patient |
| 2023 | Appropriate Term / Code Not Available | 1 | Patient |
| 2023 | Self-Activation or Keying | 1 | Device |
| 2023 | Naturally Worn | 2 | Device |
| 2023 | Intermittent Energy Output | 2 | Device |
| 2023 | Failure to Fire | 8 | Device |
| 2023 | Failure to Deliver Energy | 1 | Device |
| 2023 | Failure to Cut | 1 | Device |
| 2023 | Difficult or Delayed Activation | 1 | Device |
| 2023 | Device Remains Activated | 1 | Device |
| 2023 | Device Difficult to Setup or Prepare | 1 | Device |
| 2023 | Detachment of Device or Device Component | 18 | Device |
| 2023 | Break | 3 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2022 | Syncope/Fainting | 1 | Patient |
| 2022 | Low Blood Pressure/ Hypotension | 1 | Patient |
| 2022 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2022 | Appropriate Term / Code Not Available | 1 | Patient |
| 2022 | Self-Activation or Keying | 1 | Device |
| 2022 | Noise, Audible | 1 | Device |
| 2022 | Material Separation | 1 | Device |
| 2022 | Loose or Intermittent Connection | 1 | Device |
| 2022 | Intermittent Energy Output | 2 | Device |
| 2022 | Failure to Fire | 7 | Device |
| 2022 | Failure to Deliver Energy | 2 | Device |
| 2022 | Failure to Cut | 1 | Device |
| 2022 | Energy Output Problem | 1 | Device |
| 2022 | Difficult to Open or Close | 1 | Device |
| 2022 | Difficult or Delayed Activation | 4 | Device |
| 2022 | Detachment of Device or Device Component | 23 | Device |
| 2022 | Communication or Transmission Problem | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2022 | Activation Failure | 1 | Device |
| 2019 | Output Problem | 1 | Device |
| 2019 | Noise, Audible | 4 | Device |
| 2019 | Material Separation | 1 | Device |
| 2019 | Material Fragmentation | 35 | Device |
| 2019 | Loss of Power | 1 | Device |
| 2019 | Intermittent Energy Output | 36 | Device |
| 2019 | Insufficient Information | 2 | Device |
| 2019 | Failure to Fire | 15 | Device |
| 2019 | Difficult to Open or Close | 4 | Device |
| 2019 | Detachment of Device or Device Component | 72 | Device |
| 2019 | Defective Device | 2 | Device |
| 2019 | Break | 8 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2018 | Use of Device Problem | 1 | Device |
| 2018 | Premature Discharge of Battery | 2 | Device |
| 2018 | Peeled/Delaminated | 1 | Device |
| 2018 | Noise, Audible | 3 | Device |
| 2018 | Material Twisted/Bent | 2 | Device |
| 2018 | Material Separation | 1 | Device |
| 2018 | Material Fragmentation | 43 | Device |
| 2018 | Loss of Power | 1 | Device |
| 2018 | Intermittent Energy Output | 25 | Device |
| 2018 | Fracture | 2 | Device |
| 2018 | Flare or Flash | 2 | Device |
| 2018 | Failure to Power Up | 1 | Device |
| 2018 | Failure to Fire | 25 | Device |
| 2018 | Failure to Disconnect | 1 | Device |
| 2018 | Failure to Cut | 2 | Device |
| 2018 | Display or Visual Feedback Problem | 2 | Device |
| 2018 | Difficult to Open or Close | 1 | Device |
| 2018 | Difficult or Delayed Activation | 4 | Device |
| 2018 | Device Stops Intermittently | 24 | Device |
| 2018 | Device Operates Differently Than Expected | 2 | Device |
| 2018 | Device Inoperable | 1 | Device |
| 2018 | Device Displays Incorrect Message | 1 | Device |
| 2018 | Device Difficult to Setup or Prepare | 4 | Device |
| 2018 | Device Damaged Prior to Use | 5 | Device |
| 2018 | Detachment of Device or Device Component | 49 | Device |
| 2018 | Detachment Of Device Component | 57 | Device |
| 2018 | Defective Device | 6 | Device |
| 2018 | Defective Component | 1 | Device |
| 2018 | Crack | 1 | Device |
| 2018 | Connection Problem | 1 | Device |
| 2018 | Component Missing | 3 | Device |
| 2018 | Component Falling | 1 | Device |
| 2018 | Break | 31 | Device |
| 2018 | Battery Problem | 3 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 11 | Device |
| 2018 | Activation, Positioning or Separation Problem | 1 | Device |
| 2017 | Self-Activation or Keying | 2 | Device |
| 2017 | Overheating of Device | 1 | Device |
| 2017 | Noise, Audible | 1 | Device |
| 2017 | Material Fragmentation | 1 | Device |
| 2017 | Intermittent Energy Output | 3 | Device |
| 2017 | Insufficient Information | 1 | Device |
| 2017 | Fracture | 3 | Device |
| 2017 | Fire | 1 | Device |
| 2017 | Failure to Power Up | 1 | Device |
| 2017 | Failure to Form Staple | 1 | Device |
| 2017 | Failure to Fire | 32 | Device |
| 2017 | Failure to Deliver Energy | 5 | Device |
| 2017 | Failure to Charge | 1 | Device |
| 2017 | Failure To Adhere Or Bond | 1 | Device |
| 2017 | Energy Output To Patient Tissue Incorrect | 2 | Device |
| 2017 | Difficult or Delayed Activation | 2 | Device |
| 2017 | Device Stops Intermittently | 31 | Device |
| 2017 | Device Operates Differently Than Expected | 4 | Device |
| 2017 | Device Inoperable | 3 | Device |
| 2017 | Device Displays Incorrect Message | 3 | Device |
| 2017 | Device Difficult to Setup or Prepare | 2 | Device |
| 2017 | Device Damaged Prior to Use | 3 | Device |
| 2017 | Detachment of Device or Device Component | 5 | Device |
| 2017 | Detachment Of Device Component | 144 | Device |
| 2017 | Defective Device | 3 | Device |
| 2017 | Component Missing | 1 | Device |
| 2017 | Break | 12 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 9 | Device |
| 2016 | Loss of Power | 2 | Device |
| 2016 | Fracture | 45 | Device |
| 2016 | Failure to Power Up | 1 | Device |
| 2016 | Failure to Deliver Energy | 1 | Device |
| 2016 | Device Stops Intermittently | 5 | Device |
| 2016 | Device Operates Differently Than Expected | 3 | Device |
| 2016 | Device Inoperable | 4 | Device |
| 2016 | Detachment Of Device Component | 12 | Device |
| 2016 | Defective Device | 1 | Device |
| 2016 | Component Missing | 1 | Device |
| 2016 | Break | 1 | Device |
| 2015 | Smoking | 1 | Device |
| 2015 | Self-Activation or Keying | 1 | Device |
| 2015 | Noise, Audible | 1 | Device |
| 2015 | Insufficient Information | 1 | Device |
| 2015 | Fracture | 1 | Device |
| 2015 | Disconnection | 3 | Device |
| 2015 | Difficult or Delayed Activation | 1 | Device |
| 2015 | Device Stops Intermittently | 3 | Device |
| 2015 | Device Operates Differently Than Expected | 4 | Device |
| 2015 | Device Emits Odor | 1 | Device |
| 2015 | Device Displays Incorrect Message | 1 | Device |
| 2015 | Detachment of Device or Device Component | 2 | Device |
| 2015 | Detachment Of Device Component | 10 | Device |
| 2015 | Component Falling | 4 | Device |
| 2015 | Break | 1 | Device |
| 2014 | Loss of Power | 1 | Device |
| 2014 | Fracture | 2 | Device |
| 2014 | Difficult or Delayed Activation | 1 | Device |
| 2014 | Detachment Of Device Component | 1 | Device |