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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 4568 4568
2026 1843 1843

Device Problems MDRs with this Device Problem Events in those MDRs
Poor Quality Image 4420 4420
No Display/Image 1277 1277
Break 1194 1194
Communication or Transmission Problem 1001 1001
Dent in Material 633 633
Erratic or Intermittent Display 467 467
Optical Discoloration 429 429
Material Split, Cut or Torn 344 344
Output Problem 329 329
Scratched Material 295 295
Fracture 295 295
Crack 283 283
Leak/Splash 238 238
Optical Problem 234 234
Loose or Intermittent Connection 231 231
Image Display Error/Artifact 224 224
Material Twisted/Bent 216 216
Display or Visual Feedback Problem 191 191
Failure to Cut 182 182
Failure to Clean Adequately 178 178
Material Deformation 139 139
Material Integrity Problem 122 122
Gas/Air Leak 103 103
Image Orientation Incorrect 78 78
Mechanical Problem 77 77
Connection Problem 77 77
Detachment of Device or Device Component 76 76
Degraded 68 68
Sharp Edges 65 65
Defective Component 61 61
Material Puncture/Hole 52 52
No Device Output 46 46
Electrical /Electronic Property Problem 39 39
Corroded 38 38
Contamination 38 38
Defective Device 36 36
Unstable 36 36
Unexpected Color 29 29
Insufficient Heating 27 27
Material Discolored 25 25
Unintended Movement 23 23
Fogging 23 23
Difficult to Open or Close 22 22
Display Difficult to Read 20 20
Moisture or Humidity Problem 18 18
Material Fragmentation 17 17
Circuit Failure 17 17
Adverse Event Without Identified Device or Use Problem 16 16
Electrical Overstress 15 15
Material Separation 15 15

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10977 10977
Insufficient Information 55 55
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
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
Needle Stick/Puncture 1 1
Numbness 1 1
Respiratory Tract Infection 1 1
Ecchymosis 1 1
Laceration(s) 1 1
Pain 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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