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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device laparoscopic accessories, gynecologic
Regulation Description Gynecologic laparoscope and accessories.
Definition Exempt laparoscope accessories are non-powered, non-inflatable, simple manual mechanical devices, e.g., cannula, graspers, forceps, dissectors, scissors, etc. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.
Product CodeNWV
Regulation Number 884.1720
Device Class 1

MDR Year MDR Reports MDR Events
2021 123 123
2022 20 20
2023 25 25
2024 31 31
2025 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Break 87 87
Material Separation 46 46
Detachment of Device or Device Component 23 23
Material Integrity Problem 18 18
Material Frayed 15 15
Material Fragmentation 8 8
Difficult to Open or Close 6 6
Mechanical Problem 5 5
Solder Joint Fracture 4 4
Fracture 4 4
Mechanical Jam 4 4
Insufficient Information 3 3
Sharp Edges 3 3
Device Contaminated During Manufacture or Shipping 2 2
Entrapment of Device 2 2
Physical Resistance/Sticking 2 2
Patient Device Interaction Problem 2 2
Material Rupture 2 2
No Apparent Adverse Event 2 2
Flaked 2 2
Loss of or Failure to Bond 2 2
Leak/Splash 1 1
Material Split, Cut or Torn 1 1
Collapse 1 1
Separation Failure 1 1
Device Fell 1 1
Contamination 1 1
Difficult to Remove 1 1
Infusion or Flow Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Product Quality Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Component Incompatible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 187 187
Insufficient Information 12 12
Foreign Body In Patient 5 5
Bowel Perforation 2 2
Physical Entrapment 2 2
Unspecified Gastrointestinal Problem 1 1
Inflammation 1 1
Erythema 1 1
Laceration(s) 1 1
Perforation of Vessels 1 1
Hemorrhage/Bleeding 1 1
Device Embedded In Tissue or Plaque 1 1

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