BIOPSY INSTRUMENT
This device is manufactured by BARD PERIPHERAL VASCULAR, BARD REYNOSA SA DE CV, CR BARD (COVINGTON) -1018233.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2023 | Pneumothorax | 1 | Patient |
| 2023 | Failure to Obtain Sample | 3 | Device |
| 2023 | Dull, Blunt | 1 | Device |
| 2023 | Difficult to Insert | 1 | Device |
| 2022 | Self-Activation or Keying | 6 | Device |
| 2022 | Failure to Obtain Sample | 2 | Device |
| 2022 | Failure to Fire | 4 | Device |
| 2022 | Device Markings/Labelling Problem | 1 | Device |
| 2022 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2020 | Self-Activation or Keying | 2 | Device |
| 2020 | Material Twisted/Bent | 1 | Device |
| 2019 | Self-Activation or Keying | 20 | Device |
| 2019 | Material Twisted/Bent | 4 | Device |
| 2019 | Failure to Prime | 6 | Device |
| 2019 | Failure to Obtain Sample | 3 | Device |
| 2019 | Failure to Fire | 3 | Device |
| 2019 | Device Markings/Labelling Problem | 1 | Device |
| 2019 | Break | 1 | Device |
| 2018 | Self-Activation or Keying | 467 | Device |
| 2018 | Positioning Problem | 1 | Device |
| 2018 | Noise, Audible | 2 | Device |
| 2018 | No Fail-Safe Mechanism | 1 | Device |
| 2018 | No Apparent Adverse Event | 1 | Device |
| 2018 | Misfire | 3 | Device |
| 2018 | Mechanical Problem | 1 | Device |
| 2018 | Material Twisted/Bent | 2 | Device |
| 2018 | Insufficient Information | 1 | Device |
| 2018 | Failure to Prime | 172 | Device |
| 2018 | Failure to Obtain Sample | 27 | Device |
| 2018 | Failure to Fire | 26 | Device |
| 2018 | Difficult to Remove | 4 | Device |
| 2018 | Difficult to Advance | 1 | Device |
| 2018 | Device Markings/Labelling Problem | 3 | Device |
| 2018 | Device Contamination with Chemical or Other Material | 2 | Device |
| 2018 | Bent | 1 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2018 | Activation, Positioning or Separation Problem | 1 | Device |
| 2018 | Activation Problem | 1 | Device |
| 2017 | Shelf Life Exceeded | 1 | Device |
| 2017 | Self-Activation or Keying | 366 | Device |
| 2017 | Noise, Audible | 1 | Device |
| 2017 | Material Fragmentation | 1 | Device |
| 2017 | Material Discolored | 1 | Device |
| 2017 | Failure to Prime | 175 | Device |
| 2017 | Failure to Obtain Sample | 16 | Device |
| 2017 | Failure to Fire | 15 | Device |
| 2017 | Dull, Blunt | 3 | Device |
| 2017 | Difficult to Remove | 3 | Device |
| 2017 | Difficult or Delayed Activation | 1 | Device |
| 2017 | Device Operates Differently Than Expected | 5 | Device |
| 2017 | Device Markings/Labelling Problem | 1 | Device |
| 2017 | Device Contamination with Chemical or Other Material | 7 | Device |
| 2017 | Detachment of Device or Device Component | 1 | Device |
| 2017 | Break | 3 | Device |
| 2017 | Bent | 4 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 5 | Device |