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U.S. Department of Health and Human Services

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


Premarket Reviews
ManufacturerDecision
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
CORE ACCESS SURGICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
FREYJA HEALTHCARE, LLC
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG OPTOMEDIC TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
HANGZHOU KANGJI MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ SE & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
OLYMPUS MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PALLIARE , LTD.
  SUBSTANTIALLY EQUIVALENT 2
PREMIUM MEDICAL TECHNOLOGY, LLC
  SUBSTANTIALLY EQUIVALENT 1
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SMARTSURGN, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TAUTONA GROUP
  SUBSTANTIALLY EQUIVALENT 1
TAUTONA GROUP RESEARCH & DEVELOPMENT, CO., LLC
  SUBSTANTIALLY EQUIVALENT 1
WEYO SURGICAL TECHNOLOGY , LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 654 654
2022 667 671
2023 890 890
2024 1482 1482
2025 1517 1519
2026 1296 1296

Device Problems MDRs with this Device Problem Events in those MDRs
Pressure Problem 758 758
Gas/Air Leak 525 525
No Display/Image 456 456
Display or Visual Feedback Problem 363 364
Adverse Event Without Identified Device or Use Problem 343 343
Failure to Power Up 303 303
Electrical /Electronic Property Problem 270 270
Break 209 209
Output Problem 204 204
Unexpected Shutdown 196 196
Gas Output Problem 192 193
Circuit Failure 186 186
No Visual Prompts/Feedback 178 178
Loss of Power 176 176
Decrease in Pressure 163 163
Leak/Splash 153 153
Increase in Pressure 152 152
No Device Output 150 150
Power Problem 143 143
Insufficient Flow or Under Infusion 132 132
Audible Prompt/Feedback Problem 121 121
No Flow 113 113
Defective Component 106 106
Device Alarm System 105 105
Prophylactic removal due to corrective action 103 103
Infusion or Flow Problem 100 100
Activation Failure 97 97
Erratic or Intermittent Display 89 89
Improper Flow or Infusion 86 86
Intermittent Loss of Power 79 79
Communication or Transmission Problem 76 76
Noise, Audible 74 74
Free or Unrestricted Flow 62 62
Corroded 60 60
Degraded 57 57
Detachment of Device or Device Component 55 55
Crack 54 54
Excess Flow or Over-Infusion 47 47
Restricted Flow rate 47 47
Insufficient Device Problem Information 46 46
Inaccurate Flow Rate 46 46
Inflation Problem 42 42
Key or Button Unresponsive/not Working 42 42
Incorrect, Inadequate or Imprecise Result or Readings 42 42
Fail-Safe Did Not Operate 42 42
Defective Alarm 39 39
Mechanical Problem 37 37
Complete Loss of Power 36 36
Component Missing 28 28
No Pressure 28 28

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5863 5865
Air Embolism 252 252
Insufficient Information 108 112
No Consequences Or Impact To Patient 86 86
Cardiac Arrest 40 40
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 35 35
Bradycardia 24 24
Pneumothorax 23 23
Bowel Perforation 16 16
Hemorrhage/Blood Loss/Bleeding 15 15
Hypothermia 12 12
Infiltration into Tissue 12 12
Pulmonary Emphysema 10 10
Abdominal Pain 9 9
Stroke/CVA 9 9
Unspecified Respiratory Problem 9 9
Abdominal Distention 9 9
Embolism/Embolus 8 8
Burn(s) 6 6
Unspecified Tissue Injury 6 6
Perforation 6 6
Low Oxygen Saturation 6 6
Swelling/ Edema 5 5
Asystole 5 5
Low Blood Pressure/ Hypotension 5 5
Dyspnea 5 5
No Patient Involvement 5 5
Tachycardia 4 4
Skin Disorders 4 4
Pneumoperitoneum 4 4
Partial thickness (Second Degree) Burn 3 3
Respiratory Insufficiency 3 3
Pain 3 3
Laceration(s) 3 3
Ischemia Stroke 3 3
Foreign Body In Patient 3 3
Hypoxia 2 2
Caustic/Chemical Burns 2 2
Hyperthermia 2 2
Airway Obstruction 2 2
Tissue Breakdown 2 2
Pulmonary Embolism 2 2
Arrhythmia 2 2
Mediastinal Shift 2 2
Paralysis 2 2
Respiratory Arrest 2 2
Respiratory Acidosis 2 2
Electrolyte Imbalance 2 2
Rupture 2 2
High Blood Pressure/ Hypertension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ConMed Corporation II Jun-17-2026
2 Northgate Technologies, Inc. II Feb-24-2021
3 Olympus Corporation of the Americas II Jul-22-2026
4 Olympus Corporation of the Americas I Feb-18-2026
5 Olympus Corporation of the Americas II Mar-25-2024
6 Olympus Corporation of the Americas I Oct-18-2023
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