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TPLC
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Device
insufflator, carbon-dioxide, uterotubal (and accessories)
Product Code
HES
Regulation Number
884.1300
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
Entrapment of Device
1
1
Device Contamination with Body Fluid
1
1
Burst Container or Vessel
1
1
Difficult to Insert
1
1
Fluid/Blood Leak
1
1
Wire(s), breakage of
1
1
Use of Device Problem
1
1
Device Inoperable
1
1
Defective Component
1
1
Detachment of Device or Device Component
1
1
Material Separation
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
Abdominal Pain
1
1
Nausea
1
1
Adhesion(s)
1
1
Cyst(s)
1
1
Hematoma
1
1
Foreign Body In Patient
1
1
Urinary Frequency
1
1
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