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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)
Regulation Description Gynecologic laparoscope and accessories.
Product CodeHET
Regulation Number 884.1720
Device Class 2


Premarket Reviews
ManufacturerDecision
270SURGICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  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 1
SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 49 49
2021 132 132
2022 216 216
2023 824 824
2024 3497 3497
2025 510 510

Device Problems MDRs with this Device Problem Events in those MDRs
Poor Quality Image 2177 2177
No Display/Image 554 554
Break 442 442
Communication or Transmission Problem 415 415
Optical Discoloration 272 272
Dent in Material 187 187
Failure to Cut 183 183
Material Split, Cut or Torn 176 176
Erratic or Intermittent Display 172 172
Crack 164 164
Image Display Error/Artifact 148 148
Scratched Material 130 130
Display or Visual Feedback Problem 113 113
Loose or Intermittent Connection 98 98
Fracture 97 97
Optical Problem 96 96
Leak/Splash 92 92
Output Problem 87 87
Image Orientation Incorrect 61 61
Material Integrity Problem 55 55
Material Twisted/Bent 48 48
Mechanical Problem 46 46
Material Deformation 38 38
Defective Component 38 38
Detachment of Device or Device Component 36 36
Defective Device 31 31
Dull, Blunt 30 30
Material Puncture/Hole 27 27
Electrical /Electronic Property Problem 24 24
Connection Problem 23 23
Adverse Event Without Identified Device or Use Problem 22 22
Gas/Air Leak 20 20
Difficult to Open or Close 20 20
Material Discolored 20 20
Display Difficult to Read 19 19
Unexpected Color 19 19
Contamination 17 17
Mechanical Jam 16 16
Electrical Overstress 12 12
Material Fragmentation 11 11
Fluid/Blood Leak 11 11
Failure to Clean Adequately 10 10
Corroded 10 10
Circuit Failure 9 9
Moisture or Humidity Problem 9 9
Material Opacification 8 8
Fogging 7 7
Material Separation 7 7
Sharp Edges 7 7
Unintended Movement 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5109 5109
No Consequences Or Impact To Patient 32 32
Insufficient Information 28 28
No Known Impact Or Consequence To Patient 12 12
Foreign Body In Patient 9 9
Bowel Perforation 6 6
Unspecified Tissue Injury 6 6
Burn(s) 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Injury 4 4
Hemorrhage/Bleeding 3 3
Solid Tumour 3 3
No Patient Involvement 3 3
No Code Available 2 2
Pain 2 2
Laceration(s) 2 2
Fluid Discharge 1 1
Abortion 1 1
Syncope/Fainting 1 1
Impaired Healing 1 1
Hemoptysis 1 1
Numbness 1 1
Tissue Damage 1 1
Full thickness (Third Degree) Burn 1 1
Ecchymosis 1 1
Wound Dehiscence 1 1
Not Applicable 1 1
Headache 1 1
Arrhythmia 1 1
Perforation 1 1
Respiratory Tract Infection 1 1
Blood Loss 1 1
Fever 1 1
Leiomyosarcoma 1 1
Device Embedded In Tissue or Plaque 1 1
Post Operative Wound Infection 1 1
Fibrosis 1 1
Adhesion(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aizu Olympus Co., Ltd. II Nov-17-2023
2 Carefusion 2200 Inc II Mar-30-2022
3 Karl Storz Endoscopy II Apr-03-2024
4 Karl Storz Endoscopy II Dec-18-2023
5 Olympus Corporation of the Americas II Jan-10-2024
6 Olympus Corporation of the Americas II Jan-05-2024
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