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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
A.M.I. AGENCY FOR MEDICAL INNOVATIONS GMBH
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
PRECISION ROBOTICS (HONG KONG) LIMITED
  SUBSTANTIALLY EQUIVALENT 2
SCHOELLY FIBEROPTIC GMBH
  SUBSTANTIALLY EQUIVALENT 1
SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 132 132
2022 216 216
2023 824 824
2024 3496 3496
2025 4570 4570

Device Problems MDRs with this Device Problem Events in those MDRs
Poor Quality Image 3749 3749
No Display/Image 1069 1069
Break 870 870
Communication or Transmission Problem 802 802
Dent in Material 435 435
Optical Discoloration 386 386
Erratic or Intermittent Display 373 373
Material Split, Cut or Torn 288 288
Crack 238 238
Output Problem 235 235
Fracture 227 227
Scratched Material 215 215
Leak/Splash 205 205
Image Display Error/Artifact 200 200
Optical Problem 183 183
Failure to Cut 182 182
Display or Visual Feedback Problem 167 167
Loose or Intermittent Connection 159 159
Material Twisted/Bent 142 142
Material Integrity Problem 107 107
Material Deformation 105 105
Gas/Air Leak 79 79
Image Orientation Incorrect 75 75
Mechanical Problem 70 70
Detachment of Device or Device Component 63 63
Connection Problem 62 62
Defective Component 60 60
Failure to Clean Adequately 56 56
Sharp Edges 50 50
Material Puncture/Hole 46 46
Degraded 42 42
Defective Device 36 36
Corroded 33 33
Electrical /Electronic Property Problem 33 33
Contamination 31 31
Unexpected Color 27 27
No Device Output 24 24
Material Discolored 23 23
Difficult to Open or Close 22 22
Fogging 21 21
Display Difficult to Read 20 20
Insufficient Heating 19 19
Material Fragmentation 17 17
Circuit Failure 17 17
Unintended Movement 17 17
Adverse Event Without Identified Device or Use Problem 16 16
Electrical Overstress 15 15
Moisture or Humidity Problem 14 14
Dull, Blunt 13 13
Mechanical Jam 13 13

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9140 9140
Insufficient Information 51 51
Foreign Body In Patient 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Bowel Perforation 6 6
Unspecified Tissue Injury 6 6
No Consequences Or Impact To Patient 6 6
Burn(s) 5 5
Solid Tumour 3 3
Hemorrhage/Bleeding 3 3
Adhesion(s) 2 2
Peritonitis 2 2
No Patient Involvement 2 2
Pain 2 2
Abdominal Pain 1 1
Unspecified Infection 1 1
Impaired Healing 1 1
Syncope/Fainting 1 1
Wound Dehiscence 1 1
Arrhythmia 1 1
Hemoptysis 1 1
Perforation 1 1
No Known Impact Or Consequence To Patient 1 1
Fever 1 1
Numbness 1 1
Respiratory Tract Infection 1 1
Ecchymosis 1 1
Laceration(s) 1 1
Fluid Discharge 1 1
Headache 1 1
Fibrosis 1 1
Leiomyosarcoma 1 1
Abortion 1 1
Full thickness (Third Degree) Burn 1 1

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