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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

MDR Year MDR Reports MDR Events
2019 44 44
2020 49 49
2021 132 132
2022 216 216
2023 824 824
2024 197 197

Device Problems MDRs with this Device Problem Events in those MDRs
Poor Quality Image 605 605
Failure to Cut 187 187
Optical Discoloration 151 151
Image Display Error/Artifact 93 93
Break 84 84
No Display/Image 56 56
Adverse Event Without Identified Device or Use Problem 40 40
Display or Visual Feedback Problem 30 30
Dull, Blunt 29 29
Output Problem 24 24
Difficult to Open or Close 21 21
Defective Component 19 19
Detachment of Device or Device Component 19 19
Unexpected Color 17 17
Mechanical Jam 15 15
Mechanical Problem 13 13
Erratic or Intermittent Display 11 11
Electrical /Electronic Property Problem 11 11
Fluid/Blood Leak 11 11
Material Fragmentation 10 10
Crack 9 9
Display Difficult to Read 8 8
Circuit Failure 7 7
Material Deformation 7 7
Communication or Transmission Problem 7 7
Material Separation 5 5
Sparking 4 4
Device Contaminated During Manufacture or Shipping 4 4
Flare or Flash 4 4
Failure to Shut Off 3 3
Use of Device Problem 3 3
Energy Output Problem 3 3
Failure to Clean Adequately 3 3
Separation Problem 2 2
Insufficient Information 2 2
Material Split, Cut or Torn 2 2
Physical Resistance/Sticking 2 2
Peeled/Delaminated 2 2
Unexpected Therapeutic Results 2 2
Thermal Decomposition of Device 2 2
Failure to Deliver Energy 2 2
Component Missing 2 2
Defective Device 2 2
Arcing 2 2
Scratched Material 2 2
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Packaging Problem 1 1
Protective Measures Problem 1 1
Optical Distortion 1 1
Electrical Shorting 1 1
Device Contamination with Chemical or Other Material 1 1
Gas/Air Leak 1 1
Human-Device Interface Problem 1 1
Device Markings/Labelling Problem 1 1
Deformation Due to Compressive Stress 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Align 1 1
Improper or Incorrect Procedure or Method 1 1
Insufficient Flow or Under Infusion 1 1
Fitting Problem 1 1
Corroded 1 1
Image Orientation Incorrect 1 1
Labelling, Instructions for Use or Training Problem 1 1
Leak/Splash 1 1
Loose or Intermittent Connection 1 1
Device Slipped 1 1
Melted 1 1
Delivered as Unsterile Product 1 1
Loss of Power 1 1
Failure to Power Up 1 1
Failure to Pump 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Retraction 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 1317 1317
No Consequences Or Impact To Patient 44 44
Injury 19 19
No Known Impact Or Consequence To Patient 18 18
No Code Available 13 13
Insufficient Information 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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