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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
2020 105 105
2021 123 123
2022 20 20
2023 25 25
2024 31 31
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 168 168
Material Separation 53 53
Detachment of Device or Device Component 25 25
Material Integrity Problem 20 20
Material Frayed 15 15
Mechanical Problem 14 14
Mechanical Jam 10 10
Difficult to Open or Close 7 7
Material Fragmentation 7 7
Patient Device Interaction Problem 6 6
Fracture 5 5
Solder Joint Fracture 4 4
Insufficient Information 3 3
Material Twisted/Bent 2 2
Sharp Edges 2 2
Physical Resistance/Sticking 2 2
Loss of or Failure to Bond 2 2
Flaked 2 2
Entrapment of Device 2 2
Component Incompatible 1 1
Material Split, Cut or Torn 1 1
Device Contaminated During Manufacture or Shipping 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Infusion or Flow Problem 1 1
Collapse 1 1
Tear, Rip or Hole in Device Packaging 1 1
Separation Failure 1 1
Leak/Splash 1 1
Difficult to Remove 1 1
Contamination 1 1
Device Fell 1 1
Fitting Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 223 223
No Patient Involvement 28 28
No Consequences Or Impact To Patient 20 20
No Known Impact Or Consequence To Patient 20 20
Foreign Body In Patient 15 15
Insufficient Information 12 12
Bowel Perforation 6 6
Device Embedded In Tissue or Plaque 2 2
Patient Problem/Medical Problem 2 2
Physical Entrapment 2 2
Hemorrhage/Bleeding 1 1
Inflammation 1 1
Unspecified Gastrointestinal Problem 1 1
Laceration(s) 1 1
Erythema 1 1
Perforation of Vessels 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Applied Medical Resources Corp II May-28-2020
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