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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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 912 912

Device Problems MDRs with this Device Problem Events in those MDRs
Poor Quality Image 901 901
Failure to Cut 187 187
Optical Discoloration 178 178
No Display/Image 160 160
Break 130 130
Image Display Error/Artifact 100 100
Communication or Transmission Problem 86 86
Display or Visual Feedback Problem 50 50
Crack 40 40
Erratic or Intermittent Display 40 40
Adverse Event Without Identified Device or Use Problem 40 40
Output Problem 36 36
Dull, Blunt 29 29
Scratched Material 26 26
Material Split, Cut or Torn 26 26
Detachment of Device or Device Component 22 22
Mechanical Problem 22 22
Difficult to Open or Close 21 21
Defective Component 21 21
Unexpected Color 17 17
Dent in Material 16 16
Leak/Splash 16 16
Electrical /Electronic Property Problem 15 15
Mechanical Jam 15 15
Display Difficult to Read 14 14
Loose or Intermittent Connection 13 13
Fluid/Blood Leak 12 12
Material Integrity Problem 12 12
Material Puncture/Hole 11 11
Material Fragmentation 10 10
Material Deformation 10 10
Optical Problem 10 10
Image Orientation Incorrect 8 8
Defective Device 8 8
Connection Problem 7 7
Circuit Failure 7 7
Gas/Air Leak 5 5
Material Separation 5 5
Flare or Flash 4 4
Sparking 4 4
Device Contaminated During Manufacture or Shipping 4 4
Optical Obstruction 3 3
Failure to Clean Adequately 3 3
Electrical Shorting 3 3
Failure to Shut Off 3 3
Energy Output Problem 3 3
Use of Device Problem 3 3
Fracture 3 3
Peeled/Delaminated 2 2
Thermal Decomposition of Device 2 2
Contamination 2 2
Corroded 2 2
Degraded 2 2
Failure to Deliver Energy 2 2
Component Missing 2 2
Unexpected Therapeutic Results 2 2
Arcing 2 2
Insufficient Information 2 2
Physical Resistance/Sticking 2 2
Separation Problem 2 2
Unintended Movement 2 2
Optical Distortion 2 2
Moisture or Humidity Problem 1 1
Material Twisted/Bent 1 1
No Apparent Adverse Event 1 1
Therapeutic or Diagnostic Output Failure 1 1
Packaging Problem 1 1
Protective Measures Problem 1 1
Key or Button Unresponsive/not Working 1 1
Sharp Edges 1 1
Device Fell 1 1
Intermittent Loss of Power 1 1
Excessive Heating 1 1
Missing Information 1 1
Device Displays Incorrect Message 1 1
Deformation Due to Compressive Stress 1 1
Device Markings/Labelling Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Human-Device Interface Problem 1 1
Device Slipped 1 1
No Device Output 1 1
Product Quality Problem 1 1
Retraction Problem 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
Material Discolored 1 1
Loss of or Failure to Bond 1 1
Intermittent Continuity 1 1
Device Reprocessing Problem 1 1
Loss of Power 1 1
Failure to Power Up 1 1
Failure to Pump 1 1
Melted 1 1
Moisture Damage 1 1
Delivered as Unsterile Product 1 1
Unintended System Motion 1 1
Insufficient Heating 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2026 2026
No Consequences Or Impact To Patient 44 44
Injury 19 19
Insufficient Information 19 19
No Known Impact Or Consequence To Patient 18 18
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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