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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
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
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 1
SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K210116  Video Endoscopy System, 3D Video Endoscopy System

MDR Year MDR Reports MDR Events
2019 44 44
2020 49 49
2021 132 132
2022 216 216
2023 824 824
2024 404 404

Device Problems MDRs with this Device Problem Events in those MDRs
Poor Quality Image 702 702
Failure to Cut 187 187
Optical Discoloration 159 159
No Display/Image 100 100
Image Display Error/Artifact 96 96
Break 92 92
Adverse Event Without Identified Device or Use Problem 40 40
Display or Visual Feedback Problem 35 35
Dull, Blunt 29 29
Output Problem 27 27
Communication or Transmission Problem 23 23
Difficult to Open or Close 21 21
Defective Component 20 20
Detachment of Device or Device Component 19 19
Unexpected Color 17 17
Erratic or Intermittent Display 16 16
Mechanical Jam 15 15
Mechanical Problem 14 14
Electrical /Electronic Property Problem 13 13
Crack 13 13
Fluid/Blood Leak 11 11
Display Difficult to Read 10 10
Material Fragmentation 10 10
Material Split, Cut or Torn 8 8
Circuit Failure 7 7
Material Deformation 7 7
Defective Device 5 5
Material Separation 5 5
Material Puncture/Hole 4 4
Sparking 4 4
Loose or Intermittent Connection 4 4
Device Contaminated During Manufacture or Shipping 4 4
Flare or Flash 4 4
Failure to Shut Off 3 3
Material Integrity Problem 3 3
Use of Device Problem 3 3
Leak/Splash 3 3
Energy Output Problem 3 3
Failure to Clean Adequately 3 3
Separation Problem 2 2
Physical Resistance/Sticking 2 2
Insufficient Information 2 2
Scratched Material 2 2
Peeled/Delaminated 2 2
Thermal Decomposition of Device 2 2
Failure to Deliver Energy 2 2
Image Orientation Incorrect 2 2
Fracture 2 2
Unexpected Therapeutic Results 2 2
Component Missing 2 2
Connection Problem 2 2
Gas/Air Leak 2 2
Arcing 2 2
Electrical Shorting 2 2
Device Markings/Labelling Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Human-Device Interface Problem 1 1
Optical Distortion 1 1
Optical Obstruction 1 1
Deformation Due to Compressive Stress 1 1
Device Displays Incorrect Message 1 1
Failure to Align 1 1
Dent in Material 1 1
Tear, Rip or Hole in Device Packaging 1 1
Improper or Incorrect Procedure or Method 1 1
Insufficient Flow or Under Infusion 1 1
Fitting Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Insufficient Heating 1 1
Intermittent Continuity 1 1
Corroded 1 1
Loss of Power 1 1
Failure to Power Up 1 1
Failure to Pump 1 1
Product Quality Problem 1 1
Retraction Problem 1 1
Device Slipped 1 1
No Device Output 1 1
Delivered as Unsterile Product 1 1
Unintended System Motion 1 1
Melted 1 1
Moisture Damage 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Packaging Problem 1 1
Protective Measures Problem 1 1
Device Fell 1 1
Missing Information 1 1
Key or Button Unresponsive/not Working 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1520 1520
No Consequences Or Impact To Patient 44 44
Injury 19 19
No Known Impact Or Consequence To Patient 18 18
Insufficient Information 17 17
No Code Available 13 13
Foreign Body In Patient 9 9
Bowel Perforation 6 6
Burn(s) 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Not Applicable 4 4
Exposure to Body Fluids 4 4
No Patient Involvement 3 3
Hemorrhage/Bleeding 3 3
Pain 3 3
Solid Tumour 3 3
Unspecified Tissue Injury 2 2
Laceration(s) 2 2
Device Embedded In Tissue or Plaque 2 2
Fibrosis 2 2
Wound Dehiscence 2 2
Adhesion(s) 2 2
Arrhythmia 1 1
Abdominal Pain 1 1
Abortion 1 1
Death 1 1
Ecchymosis 1 1
Fever 1 1
Headache 1 1
Hemoptysis 1 1
Impaired Healing 1 1
Numbness 1 1
Respiratory Tract Infection 1 1
Post Operative Wound Infection 1 1
Blood Loss 1 1
Abdominal Distention 1 1
Full thickness (Third Degree) Burn 1 1
Cancer 1 1
Syncope/Fainting 1 1
Leiomyosarcoma 1 1
Perforation 1 1
Tissue Damage 1 1
Fluid Discharge 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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