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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hysteroscope accessories
Regulation Description Hysteroscope and accessories.
Definition Exempt hysteroscope accessories are non-powered, non-inflatable, simple manual mechanical devices, e.g., cannula, graspers, forceps, dissectors, scissors, etc. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.
Product CodeNWW
Regulation Number 884.1690
Device Class 1

MDR Year MDR Reports MDR Events
2021 4 4
2022 4 4
2023 10 10
2024 11 12
2025 13 13
2026 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Break 22 22
Detachment of Device or Device Component 18 18
Mechanical Problem 7 7
Contamination 4 4
Material Fragmentation 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Fracture 3 3
Use of Device Problem 2 2
Component Missing 2 2
Fluid/Blood Leak 1 1
Device Sensing Problem 1 1
Difficult to Fold, Unfold or Collapse 1 1
Degraded 1 1
Positioning Failure 1 1
Failure to Sense 1 1
Difficult to Open or Close 1 1
Material Disintegration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 42 42
Foreign Body In Patient 6 6
Hemorrhage/Blood Loss/Bleeding 2 2
Superficial (First Degree) Burn 1 2
Device Embedded In Tissue or Plaque 1 1
Burn(s) 1 1
Insufficient Information 1 1
Uterine Perforation 1 1
Air Embolism 1 1

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