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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device insufflator, laparoscopic
Product CodeHIF
Regulation Number 884.1730
Device Class 2


Premarket Reviews
ManufacturerDecision
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
CORE ACCESS SURGICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
FREYJA HEALTHCARE, LLC
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG OPTOMEDIC TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU T.K MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU KANGJI MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LEXION MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
PALLIARE LTD.
  SUBSTANTIALLY EQUIVALENT 4
PREMIUM MEDICAL TECHNOLOGY LLC
  SUBSTANTIALLY EQUIVALENT 1
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TAUTONA GROUP RESEARCH & DEVELOPMENT, CO. LLC
  SUBSTANTIALLY EQUIVALENT 1
W.O.M. WORLD OF MEDICINE GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 128 128
2020 360 360
2021 654 654
2022 667 667
2023 890 890
2024 541 541

Device Problems MDRs with this Device Problem Events in those MDRs
Pressure Problem 355 355
No Display/Image 257 257
Electrical /Electronic Property Problem 255 255
Failure to Power Up 208 208
Display or Visual Feedback Problem 172 172
Adverse Event Without Identified Device or Use Problem 172 172
Gas/Air Leak 142 142
Loss of Power 120 120
Break 119 119
Power Problem 95 95
Output Problem 84 84
Audible Prompt/Feedback Problem 80 80
No Visual Prompts/Feedback 79 79
Gas Output Problem 79 79
Decrease in Pressure 70 70
Increase in Pressure 69 69
Device Alarm System 68 68
Defective Component 64 64
Leak/Splash 57 57
No Device Output 50 50
Intermittent Loss of Power 50 50
Erratic or Intermittent Display 48 48
Defective Device 47 47
Improper Flow or Infusion 46 46
Unexpected Shutdown 46 46
No Flow 45 45
Insufficient Information 45 45
Infusion or Flow Problem 43 43
Free or Unrestricted Flow 42 42
Noise, Audible 39 39
Communication or Transmission Problem 38 38
Insufficient Flow or Under Infusion 37 37
Circuit Failure 36 36
Fail-Safe Did Not Operate 35 35
Material Fragmentation 34 34
Incorrect, Inadequate or Imprecise Result or Readings 34 34
Inflation Problem 33 33
Inaccurate Flow Rate 28 28
Detachment of Device or Device Component 26 26
Excess Flow or Over-Infusion 25 25
Mechanical Problem 21 21
Complete Loss of Power 19 19
Key or Button Unresponsive/not Working 19 19
Therapeutic or Diagnostic Output Failure 18 18
Restricted Flow rate 17 17
Contamination 17 17
Defective Alarm 17 17
Backflow 16 16
Connection Problem 16 16
No Pressure 13 13
Disconnection 13 13
Fluid/Blood Leak 12 12
Tear, Rip or Hole in Device Packaging 12 12
No Apparent Adverse Event 12 12
Electrical Power Problem 11 11
Crack 11 11
Device Reprocessing Problem 10 10
Nonstandard Device 10 10
Patient Device Interaction Problem 10 10
Appropriate Term/Code Not Available 9 9
Failure to Auto Stop 9 9
Component Missing 9 9
Corroded 9 9
Energy Output Problem 8 8
Overheating of Device 8 8
Device Contamination with Chemical or Other Material 8 8
Device Sensing Problem 8 8
Material Deformation 8 8
Failure to Clean Adequately 8 8
Device Displays Incorrect Message 7 7
Contamination /Decontamination Problem 6 6
Application Program Problem 6 6
Loose or Intermittent Connection 6 6
Smoking 6 6
Use of Device Problem 6 6
Incomplete or Inadequate Connection 6 6
Image Display Error/Artifact 5 5
Poor Quality Image 5 5
Unintended Collision 5 5
Thermal Decomposition of Device 5 5
No Audible Alarm 5 5
False Alarm 5 5
Failure to Shut Off 5 5
Inaccurate Delivery 5 5
Ambient Noise Problem 4 4
Suction Problem 4 4
Protective Measures Problem 4 4
Intermittent Continuity 4 4
Failure to Sense 4 4
Increase in Suction 3 3
Device Difficult to Program or Calibrate 3 3
Unable to Obtain Readings 3 3
Misconnection 3 3
Display Difficult to Read 3 3
Degraded 3 3
Temperature Problem 3 3
Material Split, Cut or Torn 3 3
Mechanical Jam 3 3
Medical Gas Supply Problem 3 3
Optical Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2483 2483
No Consequences Or Impact To Patient 337 337
No Known Impact Or Consequence To Patient 94 94
Insufficient Information 88 88
Air Embolism 43 43
Injury 31 31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 25 25
No Patient Involvement 24 24
Bradycardia 23 23
Cardiac Arrest 22 22
No Code Available 18 18
Infiltration into Tissue 12 12
Pneumothorax 12 12
Hemorrhage/Bleeding 9 9
Abdominal Distention 8 8
Unspecified Respiratory Problem 7 7
Burn(s) 7 7
Abdominal Pain 7 7
Embolism/Embolus 6 6
Swelling 5 5
Low Oxygen Saturation 5 5
Dyspnea 5 5
Pulmonary Emphysema 5 5
Perforation 5 5
Pain 5 5
Unspecified Tissue Injury 5 5
Patient Problem/Medical Problem 5 5
Foreign Body In Patient 4 4
Low Blood Pressure/ Hypotension 4 4
Laceration(s) 4 4
Stroke/CVA 4 4
Burn, Thermal 4 4
Death 4 4
Bowel Perforation 3 3
Arrhythmia 3 3
Swelling/ Edema 3 3
Respiratory Arrest 2 2
Respiratory Insufficiency 2 2
Skin Disorders 2 2
Hypothermia 2 2
Paralysis 2 2
Hypoxia 2 2
Unspecified Infection 2 2
Partial thickness (Second Degree) Burn 2 2
Test Result 2 2
Electrolyte Imbalance 2 2
Caustic/Chemical Burns 2 2
Loss Of Pulse 2 2
Chemical Exposure 1 1
Respiratory Acidosis 1 1
Low Cardiac Output 1 1
Sudden Cardiac Death 1 1
Tachycardia 1 1
Great Vessel Perforation 1 1
Rupture 1 1
Brain Injury 1 1
Stenosis 1 1
No Information 1 1
Tissue Breakdown 1 1
Forced Expiratory Volume Increased 1 1
Choking 1 1
Unspecified Vascular Problem 1 1
Asystole 1 1
Cardiovascular Insufficiency 1 1
Convulsion/Seizure 1 1
Hemorrhagic Stroke 1 1
Ischemia Stroke 1 1
Peritoneal Laceration(s) 1 1
Pneumonia 1 1
Scar Tissue 1 1
Shock 1 1
Hypovolemic Shock 1 1
High Blood Pressure/ Hypertension 1 1
Memory Loss/Impairment 1 1
Myocardial Infarction 1 1
Atrial Fibrillation 1 1
Abnormal Blood Gases 1 1
Airway Obstruction 1 1
Cyanosis 1 1
Cardiopulmonary Arrest 1 1
Fever 1 1
Fistula 1 1
Subcutaneous Nodule 1 1
Alteration in Body Temperature 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Northgate Technologies, Inc. II Feb-24-2021
2 Olympus Corporation of the Americas II Mar-25-2024
3 Olympus Corporation of the Americas I Oct-18-2023
4 Richard Wolf GmbH II Jul-27-2020
5 Stryker Corporation II Jun-04-2019
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