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TPLC
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show TPLC since
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Device
pneumoperitoneum needle
Definition
For establishment of a pneumoperitoneum in abdomen.
Product Code
FHO
Regulation Number
876.1500
Device Class
2
Premarket Reviews
Manufacturer
Decision
VECTEC
SUBSTANTIALLY EQUIVALENT
1
WICKIMED (HUIZHOU) MEDICAL EQUIPMENT MANUFACTURING CO.,LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
10
10
2018
2
2
2019
3
3
2020
5
5
2021
6
6
2022
4
4
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Leak/Splash
7
7
Break
6
6
Device Operates Differently Than Expected
3
3
Failure of Device to Self-Test
2
2
Defective Device
2
2
Detachment of Device or Device Component
2
2
Material Twisted/Bent
2
2
Pressure Problem
2
2
Material Split, Cut or Torn
1
1
Packaging Problem
1
1
Device Markings/Labelling Problem
1
1
Human-Device Interface Problem
1
1
Infusion or Flow Problem
1
1
Detachment Of Device Component
1
1
Difficult or Delayed Positioning
1
1
Fluid/Blood Leak
1
1
No Device Output
1
1
Difficult to Remove
1
1
Retraction Problem
1
1
Failure to Sense
1
1
Use of Device Problem
1
1
Device Damaged Prior to Use
1
1
Obstruction of Flow
1
1
Failure to Advance
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
12
12
No Clinical Signs, Symptoms or Conditions
6
6
No Information
5
5
No Patient Involvement
3
3
Insufficient Information
3
3
No Consequences Or Impact To Patient
2
2
Hemorrhage/Bleeding
1
1
Unspecified Tissue Injury
1
1
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