SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
This device is manufactured by COVIDIEN, COVIDIEN FORMERLY US SURGICAL, COVIDIEN LP NORTH HAVEN, DAVIS & GECK CARIBE, MMJ SA DE CV (USD).
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Wound Dehiscence | 3 | Patient |
| 2024 | Unintended Radiation Exposure | 2 | Patient |
| 2024 | Tissue Breakdown | 1 | Patient |
| 2024 | Pain | 1 | Patient |
| 2024 | Insufficient Information | 15 | Patient |
| 2024 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2024 | Foreign Body In Patient | 3 | Patient |
| 2024 | Unraveled Material | 1 | Device |
| 2024 | Detachment of Device or Device Component | 28 | Device |
| 2024 | Component or Accessory Incompatibility | 1 | Device |
| 2024 | Break | 27 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2023 | Wound Dehiscence | 1 | Patient |
| 2023 | Unspecified Tissue Injury | 2 | Patient |
| 2023 | Unintended Radiation Exposure | 5 | Patient |
| 2023 | Skin Inflammation/ Irritation | 1 | Patient |
| 2023 | Insufficient Information | 7 | Patient |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2023 | Foreign Body In Patient | 5 | Patient |
| 2023 | Use of Device Problem | 2 | Device |
| 2023 | Unraveled Material | 3 | Device |
| 2023 | Product Quality Problem | 1 | Device |
| 2023 | Patient-Device Incompatibility | 1 | Device |
| 2023 | Mechanical Problem | 1 | Device |
| 2023 | Material Protrusion/Extrusion | 1 | Device |
| 2023 | Insufficient Information | 1 | Device |
| 2023 | Human-Device Interface Problem | 2 | Device |
| 2023 | Dull, Blunt | 2 | Device |
| 2023 | Detachment of Device or Device Component | 50 | Device |
| 2023 | Break | 29 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2022 | Unintended Radiation Exposure | 1 | Patient |
| 2022 | Insufficient Information | 1 | Patient |
| 2022 | Unraveled Material | 1 | Device |
| 2022 | Product Quality Problem | 3 | Device |
| 2022 | Patient-Device Incompatibility | 1 | Device |
| 2022 | Material Twisted/Bent | 2 | Device |
| 2022 | Insufficient Information | 2 | Device |
| 2022 | Human-Device Interface Problem | 3 | Device |
| 2022 | Difficult to Open or Close | 1 | Device |
| 2022 | Detachment of Device or Device Component | 45 | Device |
| 2022 | Component or Accessory Incompatibility | 2 | Device |
| 2022 | Component Missing | 1 | Device |
| 2022 | Break | 34 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2019 | Unraveled Material | 3 | Device |
| 2019 | Product Quality Problem | 2 | Device |
| 2019 | Packaging Problem | 1 | Device |
| 2019 | Human-Device Interface Problem | 4 | Device |
| 2019 | Detachment of Device or Device Component | 54 | Device |
| 2019 | Component or Accessory Incompatibility | 2 | Device |
| 2019 | Break | 64 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2018 | Unraveled Material | 5 | Device |
| 2018 | Product Quality Problem | 1 | Device |
| 2018 | Patient-Device Incompatibility | 1 | Device |
| 2018 | Mechanical Problem | 2 | Device |
| 2018 | Material Twisted/Bent | 3 | Device |
| 2018 | Material Separation | 1 | Device |
| 2018 | Material Rupture | 1 | Device |
| 2018 | Material Frayed | 1 | Device |
| 2018 | Material Erosion | 1 | Device |
| 2018 | Material Deformation | 1 | Device |
| 2018 | Loss of or Failure to Bond | 1 | Device |
| 2018 | Human-Device Interface Problem | 12 | Device |
| 2018 | Entrapment of Device | 2 | Device |
| 2018 | Difficult to Remove | 1 | Device |
| 2018 | Difficult to Open or Close | 2 | Device |
| 2018 | Device Packaging Compromised | 3 | Device |
| 2018 | Device Operates Differently Than Expected | 1 | Device |
| 2018 | Device Fell | 1 | Device |
| 2018 | Detachment of Device or Device Component | 76 | Device |
| 2018 | Detachment Of Device Component | 36 | Device |
| 2018 | Component or Accessory Incompatibility | 3 | Device |
| 2018 | Component Missing | 4 | Device |
| 2018 | Break | 167 | Device |
| 2018 | Bent | 1 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2017 | Unraveled Material | 11 | Device |
| 2017 | Product Quality Problem | 23 | Device |
| 2017 | Mechanics Altered | 1 | Device |
| 2017 | Material Twisted/Bent | 1 | Device |
| 2017 | Human-Device Interface Problem | 22 | Device |
| 2017 | Device Packaging Compromised | 1 | Device |
| 2017 | Device Dislodged or Dislocated | 1 | Device |
| 2017 | Device Damaged Prior to Use | 1 | Device |
| 2017 | Detachment of Device or Device Component | 35 | Device |
| 2017 | Detachment Of Device Component | 94 | Device |
| 2017 | Degraded | 4 | Device |
| 2017 | Component Missing | 1 | Device |
| 2017 | Break | 200 | Device |
| 2017 | Bent | 6 | Device |
| 2017 | Appropriate Term/Code Not Available | 3 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2016 | Unraveled Material | 1 | Device |
| 2016 | Patient-Device Incompatibility | 1 | Device |
| 2016 | Migration or Expulsion of Device | 1 | Device |
| 2016 | Device Or Device Fragments Location Unknown | 1 | Device |
| 2016 | Detachment of Device or Device Component | 7 | Device |
| 2016 | Detachment Of Device Component | 9 | Device |
| 2016 | Component Falling | 2 | Device |
| 2016 | Break | 7 | Device |
| 2016 | Bent | 2 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2014 | Break | 1 | Device |
| 2013 | Detachment of Device or Device Component | 1 | Device |