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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pneumoperitoneum needle
Definition For establishment of a pneumoperitoneum in abdomen.
Product CodeFHO
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
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
Material Twisted/Bent 2 2
Defective Device 2 2
Detachment of Device or Device Component 2 2
Pressure Problem 2 2
Failure of Device to Self-Test 2 2
Detachment Of Device Component 1 1
No Device Output 1 1
Packaging Problem 1 1
Fluid/Blood Leak 1 1
Device Damaged Prior to Use 1 1
Device Markings/Labelling Problem 1 1
Failure to Sense 1 1
Difficult to Remove 1 1
Human-Device Interface Problem 1 1
Infusion or Flow Problem 1 1
Failure to Advance 1 1
Difficult or Delayed Positioning 1 1
Material Split, Cut or Torn 1 1
Obstruction of Flow 1 1
Use of Device Problem 1 1
Retraction Problem 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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