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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
2020 1 1
2021 4 4
2022 4 4
2023 10 10
2024 11 12
2025 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Break 11 11
Mechanical Problem 7 7
Detachment of Device or Device Component 6 6
Contamination 4 4
Material Fragmentation 4 4
Fracture 3 3
Use of Device Problem 2 2
Physical Resistance/Sticking 1 1
Difficult to Fold, Unfold or Collapse 1 1
Failure to Sense 1 1
Degraded 1 1
Positioning Failure 1 1
Component Missing 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Device Sensing Problem 1 1
Excessive Heating 1 2
Difficult to Open or Close 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28 28
Foreign Body In Patient 3 3
Hemorrhage/Bleeding 2 2
Air Embolism 1 1
Superficial (First Degree) Burn 1 2
Uterine Perforation 1 1
Burn(s) 1 1
Insufficient Information 1 1
No Consequences Or Impact To Patient 1 1
Device Embedded In Tissue or Plaque 1 1

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