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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device laparoscope, gynecologic (and accessories)
Product CodeHET
Regulation Number 884.1720
Device Class 2


Premarket Reviews
ManufacturerDecision
270SURGICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
270SURGICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON, INC.
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ ENDOSCOPY-AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
LINA MEDICAL APS
  SUBSTANTIALLY EQUIVALENT 1
MEDROBOTICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NOUVAG AG
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 4
OLYMPUS WINTER & IBE GMBH
  SUBSTANTIALLY EQUIVALENT 1
PRECISION ROBOTICS (HONG KONG) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SCHOELLY FIBEROPTIC GMBH
  SUBSTANTIALLY EQUIVALENT 1
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SEJONG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TROKAMED GMBH
  SUBSTANTIALLY EQUIVALENT 1
W.O.M. WORLD OF MEDICINE GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 175 175
2015 124 124
2016 205 205
2017 89 89
2018 53 53
2019 44 44
2020 49 49
2021 132 132
2022 216 216
2023 824 824
2024 2099 2099

Device Problems MDRs with this Device Problem Events in those MDRs
Poor Quality Image 1447 1447
No Display/Image 318 318
Break 288 288
Optical Discoloration 219 219
Failure to Cut 205 205
Communication or Transmission Problem 202 202
Appropriate Term/Code Not Available 190 190
Other (for use when an appropriate device code cannot be identified) 158 158
Image Display Error/Artifact 117 117
Erratic or Intermittent Display 101 101
Crack 92 92
Material Split, Cut or Torn 76 76
Scratched Material 75 75
Display or Visual Feedback Problem 74 74
Adverse Event Without Identified Device or Use Problem 66 66
Dent in Material 58 58
Output Problem 53 53
Loose or Intermittent Connection 51 51
Leak/Splash 49 49
Detachment of Device or Device Component 37 37
Dull, Blunt 35 35
Image Orientation Incorrect 34 34
Defective Component 32 32
Mechanical Problem 31 31
Optical Problem 29 29
Material Integrity Problem 29 29
Defective Device 25 25
Difficult to Open or Close 23 23
Insufficient Information 22 22
Physical Resistance 21 21
Detachment Of Device Component 20 20
Device Operates Differently Than Expected 20 20
Electrical /Electronic Property Problem 19 19
Display Difficult to Read 18 18
Unexpected Color 18 18
Material Puncture/Hole 18 18
Mechanical Jam 17 17
Material Deformation 16 16
Fluid/Blood Leak 16 16
Material Fragmentation 15 15
Gas/Air Leak 15 15
Fracture 14 14
Material Discolored 13 13
Connection Problem 13 13
Material Twisted/Bent 12 12
Torn Material 11 11
Material Separation 11 11
Tear, Rip or Hole in Device Packaging 10 10
Circuit Failure 8 8
Component Falling 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3211 3211
No Consequences Or Impact To Patient 228 228
Iatrogenic Source 185 185
No Code Available 177 177
No Known Impact Or Consequence To Patient 131 131
Death 56 56
Injury 50 50
Pain 42 42
Cancer 33 33
Other (for use when an appropriate patient code cannot be identified) 24 24
No Patient Involvement 22 22
Insufficient Information 22 22
Foreign Body In Patient 20 20
Surgical procedure 20 20
Blood Loss 16 16
Adhesion(s) 16 16
Treatment with medication(s) 14 14
Not Applicable 12 12
Burn(s) 10 10
No Information 10 10
Device Embedded In Tissue or Plaque 8 8
Tissue Damage 7 7
Hemorrhage/Bleeding 7 7
Bowel Perforation 6 6
Swelling 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Laceration(s) 4 4
Nausea 4 4
Exposure to Body Fluids 4 4
Inflammation 4 4
Post Operative Wound Infection 4 4
Fibrosis 4 4
Bleeding 4 4
Cyst(s) 3 3
Discomfort 3 3
Solid Tumour 3 3
Wound Dehiscence 3 3
Neurological Deficit/Dysfunction 3 3
Hernia 2 2
Abscess 2 2
Vomiting 2 2
Unspecified Tissue Injury 2 2
Discharge 2 2
Fever 2 2
Incontinence 2 2
Abdominal Pain 2 2
Abdominal Distention 2 2
Sepsis 2 2
Unspecified Infection 2 2
Electric Shock 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Aizu Olympus Co., Ltd. II Nov-17-2023
2 Carefusion 2200 Inc II Mar-30-2022
3 Ethicon, Inc. II Nov-10-2009
4 Karl Storz Endoscopy II Apr-03-2024
5 Karl Storz Endoscopy II Dec-18-2023
6 Market-Tiers Inc II Aug-02-2014
7 Olympus Corporation of the Americas II Jan-10-2024
8 Olympus Corporation of the Americas II Jan-05-2024
9 Olympus Corporation of the Americas II Feb-21-2017
10 Olympus Corporation of the Americas II Dec-10-2015
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