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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 328 328

Device Problems MDRs with this Device Problem Events in those MDRs
Pressure Problem 332 332
Electrical /Electronic Property Problem 253 253
No Display/Image 236 236
Failure to Power Up 202 202
Display or Visual Feedback Problem 169 169
Adverse Event Without Identified Device or Use Problem 165 165
Gas/Air Leak 129 129
Break 111 111
Loss of Power 105 105
Power Problem 94 94
Output Problem 76 76
Decrease in Pressure 68 68
Device Alarm System 66 66
Gas Output Problem 66 66
Audible Prompt/Feedback Problem 66 66
Increase in Pressure 65 65
No Visual Prompts/Feedback 58 58
Defective Component 57 57
Intermittent Loss of Power 47 47
Defective Device 46 46
Insufficient Information 45 45
Erratic or Intermittent Display 44 44
No Device Output 43 43
No Flow 43 43
Unexpected Shutdown 43 43
Improper Flow or Infusion 42 42
Infusion or Flow Problem 41 41
Free or Unrestricted Flow 40 40
Leak/Splash 40 40
Communication or Transmission Problem 37 37
Noise, Audible 36 36
Fail-Safe Did Not Operate 35 35
Incorrect, Inadequate or Imprecise Result or Readings 34 34
Material Fragmentation 34 34
Circuit Failure 34 34
Insufficient Flow or Under Infusion 33 33
Inflation Problem 29 29
Inaccurate Flow Rate 27 27
Detachment of Device or Device Component 26 26
Excess Flow or Over-Infusion 21 21
Mechanical Problem 21 21
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
Complete Loss of Power 16 16
Disconnection 13 13
Fluid/Blood Leak 12 12
Tear, Rip or Hole in Device Packaging 12 12
No Apparent Adverse Event 12 12
No Pressure 12 12
Electrical Power Problem 11 11
Patient Device Interaction Problem 10 10
Crack 10 10
Device Reprocessing Problem 10 10
Nonstandard Device 10 10
Appropriate Term/Code Not Available 9 9
Failure to Auto Stop 9 9
Device Contamination with Chemical or Other Material 8 8
Device Sensing Problem 8 8
Component Missing 8 8
Overheating of Device 8 8
Energy Output Problem 8 8
Corroded 8 8
Material Deformation 7 7
Failure to Clean Adequately 7 7
Incomplete or Inadequate Connection 6 6
Device Displays Incorrect Message 6 6
Application Program Problem 6 6
Contamination /Decontamination Problem 6 6
Loose or Intermittent Connection 6 6
Use of Device Problem 6 6
Smoking 6 6
Unintended Collision 5 5
Image Display Error/Artifact 5 5
Thermal Decomposition of Device 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
No Audible Alarm 4 4
Intermittent Continuity 4 4
Display Difficult to Read 3 3
Degraded 3 3
Misconnection 3 3
Poor Quality Image 3 3
Increase in Suction 3 3
Failure to Sense 3 3
Unable to Obtain Readings 3 3
Material Split, Cut or Torn 3 3
Optical Problem 3 3
Mechanical Jam 3 3
Medical Gas Supply Problem 3 3
Obstruction of Flow 3 3
Activation Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2282 2282
No Consequences Or Impact To Patient 337 337
No Known Impact Or Consequence To Patient 94 94
Insufficient Information 86 86
Air Embolism 41 41
Injury 31 31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 25 25
No Patient Involvement 24 24
Bradycardia 23 23
Cardiac Arrest 21 21
No Code Available 18 18
Infiltration into Tissue 12 12
Hemorrhage/Bleeding 9 9
Pneumothorax 8 8
Abdominal Distention 7 7
Burn(s) 7 7
Unspecified Respiratory Problem 7 7
Abdominal Pain 6 6
Embolism/Embolus 6 6
Low Oxygen Saturation 5 5
Pulmonary Emphysema 5 5
Pain 5 5
Perforation 5 5
Swelling 5 5
Unspecified Tissue Injury 5 5
Patient Problem/Medical Problem 5 5
Low Blood Pressure/ Hypotension 4 4
Laceration(s) 4 4
Death 4 4
Dyspnea 4 4
Stroke/CVA 4 4
Burn, Thermal 4 4
Foreign Body In Patient 4 4
Bowel Perforation 3 3
Arrhythmia 3 3
Swelling/ Edema 3 3
Skin Disorders 2 2
Hypoxia 2 2
Unspecified Infection 2 2
Hypothermia 2 2
Paralysis 2 2
Partial thickness (Second Degree) Burn 2 2
Test Result 2 2
Respiratory Arrest 2 2
Respiratory Insufficiency 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
Scar Tissue 1 1
Shock 1 1
Forced Expiratory Volume Increased 1 1
Choking 1 1
Rupture 1 1
Brain Injury 1 1
Stenosis 1 1
Convulsion/Seizure 1 1
Ischemia Stroke 1 1
Unspecified Vascular Problem 1 1
Asystole 1 1
Cardiovascular Insufficiency 1 1
No Information 1 1
Tissue Breakdown 1 1
Peritoneal Laceration(s) 1 1
Pneumonia 1 1
Tachycardia 1 1
Great Vessel Perforation 1 1
Electrolyte Imbalance 1 1
Hypovolemic Shock 1 1
High Blood Pressure/ Hypertension 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

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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