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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
2014 7 7
2015 23 23
2016 26 26
2017 31 31
2018 23 23
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 216 216
Material Separation 61 61
Detachment of Device or Device Component 40 40
Mechanical Problem 39 39
Detachment Of Device Component 27 27
Material Fragmentation 23 23
Material Integrity Problem 22 22
Mechanical Jam 13 13
Material Frayed 12 12
Solder Joint Fracture 10 10
Difficult to Open or Close 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Device Operates Differently Than Expected 7 7
Fracture 6 6
Physical Resistance/Sticking 6 6
Patient Device Interaction Problem 6 6
Sticking 3 3
Use of Device Problem 3 3
Defective Device 3 3
Entrapment of Device 3 3
Device Fell 2 2
Material Twisted/Bent 2 2
Tear, Rip or Hole in Device Packaging 2 2
Flaked 2 2
Arcing 2 2
Loss of or Failure to Bond 2 2
Leak/Splash 2 2
Defective Component 1 1
Contamination 1 1
Difficult to Remove 1 1
Disassembly 1 1
Insufficient Information 1 1
Component Missing 1 1
Failure to Cut 1 1
Infusion or Flow Problem 1 1
Difficult to Advance 1 1
Separation Failure 1 1
Material Deformation 1 1
Product Quality Problem 1 1
Energy Output Problem 1 1
Collapse 1 1
Torn Material 1 1
Device Contamination With Biological Material 1 1
Material Split, Cut or Torn 1 1
Component Incompatible 1 1
Device Contaminated During Manufacture or Shipping 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 240 240
No Known Impact Or Consequence To Patient 86 86
No Consequences Or Impact To Patient 79 79
Foreign Body In Patient 33 33
No Patient Involvement 33 33
Bowel Perforation 14 14
Insufficient Information 8 8
Device Embedded In Tissue or Plaque 6 6
Injury 5 5
Tissue Damage 5 5
No Information 4 4
No Code Available 3 3
Patient Problem/Medical Problem 2 2
Abdominal Pain 1 1
Unspecified Infection 1 1
Unspecified Gastrointestinal Problem 1 1
Inflammation 1 1
Blood Loss 1 1
Burn(s) 1 1
Erythema 1 1
Laceration(s) 1 1
Missing Value Reason 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
2 Applied Medical Resources Corp II Jun-07-2013
3 Cook Inc. II Jun-14-2017
4 JosNoe Medical, Inc. II Jan-30-2016
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