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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
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 3
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 256 256

Device Problems MDRs with this Device Problem Events in those MDRs
Pressure Problem 325 325
Electrical /Electronic Property Problem 253 253
No Display/Image 226 226
Failure to Power Up 194 194
Display or Visual Feedback Problem 167 167
Adverse Event Without Identified Device or Use Problem 165 165
Gas/Air Leak 124 124
Break 110 110
Loss of Power 100 100
Power Problem 93 93
Output Problem 76 76
Decrease in Pressure 66 66
Device Alarm System 65 65
Gas Output Problem 64 64
Increase in Pressure 62 62
Audible Prompt/Feedback Problem 61 61
No Visual Prompts/Feedback 57 57
Defective Component 55 55
Defective Device 46 46
Intermittent Loss of Power 46 46
Insufficient Information 44 44
Erratic or Intermittent Display 44 44
No Flow 43 43
Unexpected Shutdown 43 43
Improper Flow or Infusion 42 42
Infusion or Flow Problem 41 41
No Device Output 41 41
Free or Unrestricted Flow 38 38
Communication or Transmission Problem 37 37
Leak/Splash 37 37
Noise, Audible 36 36
Incorrect, Inadequate or Imprecise Result or Readings 34 34
Material Fragmentation 34 34
Circuit Failure 34 34
Fail-Safe Did Not Operate 34 34
Insufficient Flow or Under Infusion 32 32
Inflation Problem 28 28
Inaccurate Flow Rate 27 27
Detachment of Device or Device Component 25 25
Mechanical Problem 21 21
Excess Flow or Over-Infusion 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
Backflow 16 16
Connection Problem 16 16
Complete Loss of Power 16 16
Defective Alarm 15 15
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
Patient Device Interaction Problem 10 10
Electrical Power Problem 10 10
Device Reprocessing Problem 10 10
Nonstandard Device 10 10
Crack 9 9
Appropriate Term/Code Not Available 9 9
Failure to Auto Stop 8 8
Device Contamination with Chemical or Other Material 8 8
Device Sensing Problem 8 8
Component Missing 8 8
Corroded 8 8
Overheating of Device 8 8
Energy Output Problem 8 8
Failure to Clean Adequately 7 7
Use of Device Problem 6 6
Smoking 6 6
Device Displays Incorrect Message 6 6
Application Program Problem 6 6
Contamination /Decontamination Problem 6 6
Material Deformation 6 6
Failure to Shut Off 5 5
Inaccurate Delivery 5 5
Unintended Collision 5 5
Image Display Error/Artifact 5 5
Thermal Decomposition of Device 5 5
False Alarm 5 5
Incomplete or Inadequate Connection 5 5
No Audible Alarm 4 4
Intermittent Continuity 4 4
Loose or Intermittent Connection 4 4
Ambient Noise Problem 4 4
Suction Problem 4 4
Protective Measures Problem 4 4
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
Misconnection 3 3
Increase in Suction 3 3
Failure to Sense 3 3
Unable to Obtain Readings 3 3
Display Difficult to Read 3 3
Activation Problem 3 3
Use of Incorrect Control/Treatment Settings 2 2
Failure to Deliver Energy 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2212 2212
No Consequences Or Impact To Patient 337 337
No Known Impact Or Consequence To Patient 94 94
Insufficient Information 85 85
Air Embolism 41 41
Injury 31 31
No Patient Involvement 24 24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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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