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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 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Break 189 189
Material Separation 54 54
Detachment of Device or Device Component 34 34
Mechanical Problem 31 31
Material Integrity Problem 22 22
Material Frayed 12 12
Mechanical Jam 10 10
Solder Joint Fracture 10 10
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
Adverse Event Without Identified Device or Use Problem 2 2
Device Fell 2 2
Defective Device 2 2
Flaked 2 2
Arcing 2 2
Loss of or Failure to Bond 2 2
Entrapment of Device 2 2
Material Twisted/Bent 2 2
Tear, Rip or Hole in Device Packaging 2 2
Infusion or Flow Problem 1 1
Component Incompatible 1 1
Material Split, Cut or Torn 1 1
Device Contaminated During Manufacture or Shipping 1 1
Fitting Problem 1 1
Leak/Splash 1 1
Energy Output Problem 1 1
Collapse 1 1
Insufficient Information 1 1
Separation Failure 1 1
Defective Component 1 1
Difficult to Remove 1 1
Contamination 1 1
Improper or Incorrect Procedure or Method 1 1
Use of Device Problem 1 1
Material Deformation 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 239 239
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 19 19
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
Unspecified Gastrointestinal Problem 1 1
Inflammation 1 1
Burn(s) 1 1
Injury 1 1
Erythema 1 1
Laceration(s) 1 1
Perforation of Vessels 1 1
Hemorrhage/Bleeding 1 1
Cancer 1 1

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