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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device insufflator, carbon-dioxide, uterotubal (and accessories)
Product CodeHES
Regulation Number 884.1300
Device Class 2


Premarket Reviews
ManufacturerDecision
CAREFUSION 2200 INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 2 2
2016 5 5
2017 29 29
2018 68 68
2019 31 31
2020 16 16
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Deflation Problem 103 103
Inflation Problem 17 17
Device Operates Differently Than Expected 17 17
Material Rupture 15 15
Break 9 9
Difficult to Remove 3 3
Suction Problem 3 3
Detachment Of Device Component 2 2
Material Protrusion/Extrusion 2 2
Difficult to Insert 1 1
Burst Container or Vessel 1 1
Entrapment of Device 1 1
Fluid/Blood Leak 1 1
Defective Component 1 1
Device Contamination with Body Fluid 1 1
Wire(s), breakage of 1 1
Detachment of Device or Device Component 1 1
Material Separation 1 1
Device Inoperable 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 66 66
No Known Impact Or Consequence To Patient 61 61
No Patient Involvement 10 10
Discomfort 6 6
Pain 5 5
Device Embedded In Tissue or Plaque 3 3
No Information 2 2
Foreign Body In Patient 1 1
Urinary Frequency 1 1
Abdominal Pain 1 1
Adhesion(s) 1 1
Cyst(s) 1 1
Hematoma 1 1
Nausea 1 1

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