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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device amnioscope, transabdominal (fetoscope) (and accessories)
Regulation Description Transabdominal amnioscope (fetoscope) and accessories.
Product CodeHFA
Regulation Number 884.1600
Device Class Humanitarian Device Exemption

MDR Year MDR Reports MDR Events
2022 4 8
2023 1 1
2024 6 6
2025 22 22
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 18 18
Failure to Eject 2 2
Output Problem 1 2
Difficult or Delayed Activation 1 3
Lack of Effect 1 2
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hemorrhage/Bleeding 20 20
Failure to Anastomose 18 18
Incompetent Cervix 12 12
Hematoma 9 9
Abdominal Cramps 8 10
Bowel Perforation 6 6
Prolapse 6 6
Premature Labor 6 6
High Blood Pressure/ Hypertension 5 5
Rupture 4 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 4
Uterine Perforation 2 2
Chorioamnionitis 2 4
Bronchial Hemorrhage 2 2
Necrosis 2 2
Abdominal Distention 2 2
Bradycardia 2 2
Asystole 2 2
Headache 2 2
Unspecified Infection 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Inflammation 1 1
Cardiac Arrest 1 1
Insufficient Information 1 2
Urinary Retention 1 1
Osteolysis 1 1
Cervical Changes 1 2
Low Blood Pressure/ Hypotension 1 1

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