LAPAROSCOPE, GENERAL & PLASTIC SURGERY
This device is manufactured by COVIDIEN, COVIDIEN LP, DAVIS & GECK CARIBE, US SURGICAL PUERTO RICO.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Infection | 2 | Patient |
| 2024 | Laceration(s) | 2 | Patient |
| 2024 | Insufficient Information | 17 | Patient |
| 2024 | Foreign Body In Patient | 1 | Patient |
| 2024 | Appropriate Term / Code Not Available | 2 | Patient |
| 2024 | Vibration | 1 | Device |
| 2024 | Protective Measures Problem | 2 | Device |
| 2024 | Product Quality Problem | 4 | Device |
| 2024 | Mechanics Altered | 1 | Device |
| 2024 | Material Split, Cut or Torn | 36 | Device |
| 2024 | Leak/Splash | 36 | Device |
| 2024 | Insufficient Information | 8 | Device |
| 2024 | Inflation Problem | 2 | Device |
| 2024 | Difficult to Insert | 4 | Device |
| 2024 | Device Difficult to Setup or Prepare | 6 | Device |
| 2024 | Detachment of Device or Device Component | 27 | Device |
| 2024 | Decrease in Pressure | 5 | Device |
| 2024 | Break | 10 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2023 | Unspecified Tissue Injury | 1 | Patient |
| 2023 | Unintended Radiation Exposure | 2 | Patient |
| 2023 | Tissue Breakdown | 1 | Patient |
| 2023 | Laceration(s) | 1 | Patient |
| 2023 | Insufficient Information | 7 | Patient |
| 2023 | Foreign Body In Patient | 3 | Patient |
| 2023 | Protective Measures Problem | 1 | Device |
| 2023 | Noise, Audible | 2 | Device |
| 2023 | Material Split, Cut or Torn | 33 | Device |
| 2023 | Leak/Splash | 33 | Device |
| 2023 | Difficult to Remove | 2 | Device |
| 2023 | Difficult to Insert | 4 | Device |
| 2023 | Detachment of Device or Device Component | 24 | Device |
| 2023 | Decrease in Pressure | 5 | Device |
| 2023 | Break | 14 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2022 | Product Quality Problem | 2 | Device |
| 2022 | Material Split, Cut or Torn | 9 | Device |
| 2022 | Leak/Splash | 9 | Device |
| 2022 | Difficult to Remove | 1 | Device |
| 2022 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2022 | Detachment of Device or Device Component | 6 | Device |
| 2022 | Decrease in Pressure | 1 | Device |
| 2022 | Break | 8 | Device |
| 2021 | Foreign Body In Patient | 1 | Patient |
| 2021 | Detachment of Device or Device Component | 1 | Device |
| 2019 | Packaging Problem | 118 | Device |
| 2019 | Noise, Audible | 2 | Device |
| 2019 | Mechanical Problem | 1 | Device |
| 2019 | Mechanical Jam | 1 | Device |
| 2019 | Material Split, Cut or Torn | 1 | Device |
| 2019 | Leak/Splash | 73 | Device |
| 2019 | Insufficient Information | 1 | Device |
| 2019 | Human-Device Interface Problem | 2 | Device |
| 2019 | Gas/Air Leak | 1 | Device |
| 2019 | Difficult to Remove | 15 | Device |
| 2019 | Difficult to Insert | 10 | Device |
| 2019 | Device Dislodged or Dislocated | 1 | Device |
| 2019 | Detachment of Device or Device Component | 55 | Device |
| 2019 | Decrease in Pressure | 2 | Device |
| 2019 | Contamination /Decontamination Problem | 1 | Device |
| 2019 | Component or Accessory Incompatibility | 1 | Device |
| 2019 | Break | 14 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2018 | Sediment, Precipitate Or Deposit In Device Or Device Ingredient | 1 | Device |
| 2018 | Retraction Problem | 1 | Device |
| 2018 | Product Quality Problem | 1 | Device |
| 2018 | Packaging Problem | 96 | Device |
| 2018 | Noise, Audible | 11 | Device |
| 2018 | Mechanics Altered | 1 | Device |
| 2018 | Mechanical Problem | 1 | Device |
| 2018 | Material Split, Cut or Torn | 6 | Device |
| 2018 | Material Rupture | 1 | Device |
| 2018 | Loss of or Failure to Bond | 1 | Device |
| 2018 | Leak/Splash | 59 | Device |
| 2018 | Gas/Air Leak | 25 | Device |
| 2018 | Difficult to Remove | 6 | Device |
| 2018 | Difficult to Open or Close | 1 | Device |
| 2018 | Difficult to Insert | 12 | Device |
| 2018 | Difficult or Delayed Positioning | 2 | Device |
| 2018 | Device Packaging Compromised | 25 | Device |
| 2018 | Device Fell | 2 | Device |
| 2018 | Device Contamination with Chemical or Other Material | 3 | Device |
| 2018 | Detachment of Device or Device Component | 54 | Device |
| 2018 | Detachment Of Device Component | 29 | Device |
| 2018 | Deflation Problem | 1 | Device |
| 2018 | Defective Device | 1 | Device |
| 2018 | Break | 53 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2017 | Torn Material | 10 | Device |
| 2017 | Retraction Problem | 3 | Device |
| 2017 | Packaging Problem | 33 | Device |
| 2017 | Noise, Audible | 8 | Device |
| 2017 | Melted | 1 | Device |
| 2017 | Mechanics Altered | 1 | Device |
| 2017 | Mechanical Problem | 1 | Device |
| 2017 | Material Rupture | 1 | Device |
| 2017 | Material Fragmentation | 1 | Device |
| 2017 | Material Deformation | 10 | Device |
| 2017 | Leak/Splash | 39 | Device |
| 2017 | Insufficient Information | 1 | Device |
| 2017 | Human-Device Interface Problem | 1 | Device |
| 2017 | Gas/Air Leak | 1 | Device |
| 2017 | Flare or Flash | 1 | Device |
| 2017 | Failure to Fire | 1 | Device |
| 2017 | Environmental Particulates | 1 | Device |
| 2017 | Difficult to Remove | 12 | Device |
| 2017 | Difficult to Insert | 17 | Device |
| 2017 | Device Packaging Compromised | 56 | Device |
| 2017 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2017 | Detachment of Device or Device Component | 1 | Device |
| 2017 | Detachment Of Device Component | 55 | Device |
| 2017 | Break | 16 | Device |
| 2017 | Bent | 2 | Device |
| 2017 | Air Leak | 1 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2016 | Torn Material | 9 | Device |
| 2016 | Tear, Rip or Hole in Device Packaging | 2 | Device |
| 2016 | Stretched | 1 | Device |
| 2016 | Sticking | 1 | Device |
| 2016 | Retraction Problem | 1 | Device |
| 2016 | Packaging Problem | 3 | Device |
| 2016 | Noise, Audible | 2 | Device |
| 2016 | Melted | 2 | Device |
| 2016 | Mechanical Problem | 3 | Device |
| 2016 | Material Rupture | 3 | Device |
| 2016 | Material Puncture/Hole | 1 | Device |
| 2016 | Material Protrusion/Extrusion | 1 | Device |
| 2016 | Material Frayed | 2 | Device |
| 2016 | Material Fragmentation | 1 | Device |
| 2016 | Material Deformation | 4 | Device |
| 2016 | Leak/Splash | 18 | Device |
| 2016 | Inflation Problem | 1 | Device |
| 2016 | Human-Device Interface Problem | 1 | Device |
| 2016 | Gas/Air Leak | 2 | Device |
| 2016 | Fitting Problem | 1 | Device |
| 2016 | Failure to Cut | 1 | Device |
| 2016 | Failure to Advance | 1 | Device |
| 2016 | Difficult to Remove | 3 | Device |
| 2016 | Difficult to Insert | 9 | Device |
| 2016 | Difficult or Delayed Positioning | 3 | Device |
| 2016 | Device Slipped | 1 | Device |
| 2016 | Device Packaging Compromised | 9 | Device |
| 2016 | Device Damaged Prior to Use | 1 | Device |
| 2016 | Device Abrasion From Instrument Or Another Object | 3 | Device |
| 2016 | Detachment of Device or Device Component | 11 | Device |
| 2016 | Detachment Of Device Component | 13 | Device |
| 2016 | Deflation Problem | 1 | Device |
| 2016 | Defective Component | 1 | Device |
| 2016 | Cut In Material | 3 | Device |
| 2016 | Component Falling | 1 | Device |
| 2016 | Burst Container or Vessel | 2 | Device |
| 2016 | Break | 25 | Device |
| 2016 | Air Leak | 16 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2015 | Torn Material | 7 | Device |
| 2015 | Material Fragmentation | 1 | Device |
| 2015 | Leak/Splash | 5 | Device |
| 2015 | Device Operates Differently Than Expected | 1 | Device |
| 2015 | Detachment of Device or Device Component | 1 | Device |
| 2015 | Component Falling | 1 | Device |
| 2015 | Break | 1 | Device |