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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device insufflator, hysteroscopic
Product CodeHIG
Regulation Number 884.1700
Device Class 2


Premarket Reviews
ManufacturerDecision
GYRUS ACMI, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ SE & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
THERMEDX LLC
  SUBSTANTIALLY EQUIVALENT 1
THERMEDX, LLC
  SUBSTANTIALLY EQUIVALENT 3
W.O.M. WORLD OF MEDICINE AG
  SUBSTANTIALLY EQUIVALENT 2
W.O.M. WORLD OF MEDICINE GMBH
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 9 9
2015 10 10
2016 10 10
2017 11 11
2018 10 10
2019 66 66
2020 31 31
2021 130 130
2022 66 66
2023 33 33
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Material Fragmentation 132 132
Leak/Splash 37 37
Adverse Event Without Identified Device or Use Problem 24 24
Incorrect Measurement 17 17
Insufficient Information 15 15
Incorrect, Inadequate or Imprecise Result or Readings 13 13
Break 11 11
Detachment of Device or Device Component 11 11
Pressure Problem 10 10
Device Operates Differently Than Expected 9 9
Infusion or Flow Problem 7 7
Use of Device Problem 7 7
Defective Device 7 7
Output Problem 7 7
Fluid/Blood Leak 6 6
Display or Visual Feedback Problem 5 5
Defective Component 5 5
Improper Flow or Infusion 5 5
Volume Accuracy Problem 5 5
Improper or Incorrect Procedure or Method 4 4
Suction Problem 4 4
Device Displays Incorrect Message 4 4
Application Program Problem 4 4
Material Rupture 4 4
Material Separation 4 4
Mechanical Problem 4 4
Excess Flow or Over-Infusion 4 4
Nonstandard Device 4 4
Insufficient Flow or Under Infusion 3 3
Calibration Problem 2 2
Crack 2 2
Connection Problem 2 2
Inaccurate Dispensing 2 2
Protective Measures Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Packaging Problem 2 2
Suction Failure 2 2
Loose or Intermittent Connection 2 2
Fracture 2 2
Burst Container or Vessel 2 2
Pumping Stopped 2 2
Shipping Damage or Problem 2 2
Device Inoperable 2 2
Mechanics Altered 2 2
Self-Activation or Keying 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Misconnection 1 1
Tear, Rip or Hole in Device Packaging 1 1
Obstruction of Flow 1 1
Failure to Calibrate 1 1
Incorrect Or Inadequate Test Results 1 1
Low Readings 1 1
Failure to Align 1 1
Failure to Cut 1 1
Contamination 1 1
No Audible Alarm 1 1
Alarm Not Visible 1 1
False Negative Result 1 1
False Reading From Device Non-Compliance 1 1
Inability to Irrigate 1 1
Delivered as Unsterile Product 1 1
No Device Output 1 1
Increase in Pressure 1 1
Failure to Prime 1 1
Off-Label Use 1 1
Separation Problem 1 1
Lack of Effect 1 1
Power Problem 1 1
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Incomplete or Inadequate Connection 1 1
No Apparent Adverse Event 1 1
Inadequate User Interface 1 1
Optical Problem 1 1
Output below Specifications 1 1
Difficult to Open or Close 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Communication or Transmission Problem 1 1
Other (for use when an appropriate device code cannot be identified) 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 200 200
No Known Impact Or Consequence To Patient 55 55
No Consequences Or Impact To Patient 41 41
Insufficient Information 20 20
No Information 8 8
No Code Available 8 8
No Patient Involvement 8 8
Hypervolemia 8 8
Pulmonary Edema 6 6
Perforation 4 4
Unspecified Heart Problem 4 4
Swelling 3 3
Cardiac Arrest 3 3
Death 2 2
Pulmonary Embolism 2 2
Air Embolism 2 2
Edema 2 2
Extravasation 2 2
Loss of consciousness 2 2
Hyponatremia 2 2
Unspecified Tissue Injury 2 2
Unspecified Kidney or Urinary Problem 1 1
Uterine Perforation 1 1
Electrolyte Imbalance 1 1
Embolism/Embolus 1 1
Thrombosis/Thrombus 1 1
Unspecified Vascular Problem 1 1
Pallor 1 1
Low Oxygen Saturation 1 1
Ischemic Heart Disease 1 1
Underdose 1 1
Blood Loss 1 1
Bronchospasm 1 1
Abdominal Distention 1 1
Bowel Perforation 1 1
Foreign Body In Patient 1 1
Heart Failure 1 1
Incomplete Induced Abortion 1 1
Brain Injury 1 1
Hypovolemia 1 1
Distress 1 1
Extubate 1 1
Fever 1 1
Hyperventilation 1 1
Low Blood Pressure/ Hypotension 1 1
Laceration(s) 1 1
Internal Organ Perforation 1 1
Peritoneal Laceration(s) 1 1
Septic Shock 1 1
Airway Obstruction 1 1
Atrial Fibrillation 1 1
Exposure to Body Fluids 1 1
Bradycardia 1 1
Dehydration 1 1
Cardiopulmonary Arrest 1 1
Cyanosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Thermedx LLC II Apr-20-2015
2 WOM World Of Medicine AG II Jan-05-2024
3 WOM World of Medicine AG II Sep-24-2021
4 WOM World of Medicine AG II Sep-30-2019
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