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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
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
2019 56 56
2020 105 105
2021 123 123
2022 20 20
2023 25 25
2024 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Break 188 188
Material Separation 54 54
Mechanical Problem 31 31
Detachment of Device or Device Component 30 30
Material Integrity Problem 22 22
Material Frayed 11 11
Solder Joint Fracture 10 10
Mechanical Jam 9 9
Difficult to Open or Close 8 8
Material Fragmentation 8 8
Patient Device Interaction Problem 6 6
Fracture 5 5
Physical Resistance/Sticking 5 5
Device Fell 2 2
Loss of or Failure to Bond 2 2
Entrapment of Device 2 2
Flaked 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Material Twisted/Bent 2 2
Arcing 2 2
Defective Device 2 2
Tear, Rip or Hole in Device Packaging 2 2
Separation Failure 1 1
Leak/Splash 1 1
Infusion or Flow Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Deformation 1 1
Insufficient Information 1 1
Material Split, Cut or Torn 1 1
Collapse 1 1
Component Incompatible 1 1
Contamination 1 1
Energy Output Problem 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Defective Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 233 233
No Known Impact Or Consequence To Patient 47 47
No Consequences Or Impact To Patient 39 39
No Patient Involvement 30 30
Foreign Body In Patient 18 18
Insufficient Information 8 8
Bowel Perforation 5 5
Device Embedded In Tissue or Plaque 3 3
Patient Problem/Medical Problem 2 2
No Code Available 1 1
Cancer 1 1
Injury 1 1
Burn(s) 1 1
Hemorrhage/Bleeding 1 1
Laceration(s) 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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