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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hysteroscope 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
2017 5 5
2019 1 1
2020 1 1
2021 4 4
2022 4 4
2023 10 10
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 7 7
Mechanical Problem 6 6
Contamination 4 4
Detachment of Device or Device Component 4 4
Fracture 3 3
Material Fragmentation 2 2
Difficult to Open or Close 2 2
Device Contamination with Chemical or Other Material 1 1
Material Protrusion/Extrusion 1 1
Physical Resistance/Sticking 1 1
Excessive Heating 1 1
Device Sensing Problem 1 1
Fluid/Blood Leak 1 1
Material Opacification 1 1
Failure to Sense 1 1
Component Missing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15 15
No Consequences Or Impact To Patient 4 4
No Known Impact Or Consequence To Patient 3 3
Device Embedded In Tissue or Plaque 1 1
Insufficient Information 1 1
Superficial (First Degree) Burn 1 1
Foreign Body In Patient 1 1
Air Embolism 1 1
Hemorrhage/Bleeding 1 1

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