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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

MDR Year MDR Reports MDR Events
2019 31 31
2020 16 16
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Deflation Problem 27 27
Material Rupture 15 15
Break 3 3
Material Separation 1 1
Use of Device Problem 1 1
Detachment of Device or Device Component 1 1
Entrapment of Device 1 1
Inflation Problem 1 1
Difficult to Remove 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 36 36
No Known Impact Or Consequence To Patient 8 8
Device Embedded In Tissue or Plaque 2 2
Urinary Frequency 1 1
Discomfort 1 1
Abdominal Pain 1 1
Adhesion(s) 1 1
Cyst(s) 1 1
Hematoma 1 1
Nausea 1 1

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