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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
  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 1216 1216

Device Problems MDRs with this Device Problem Events in those MDRs
Pressure Problem 406 406
No Display/Image 302 302
Adverse Event Without Identified Device or Use Problem 291 291
Electrical /Electronic Property Problem 267 267
Failure to Power Up 255 255
Gas/Air Leak 190 190
Display or Visual Feedback Problem 189 189
Loss of Power 137 137
Break 126 126
No Visual Prompts/Feedback 120 120
Output Problem 110 110
Power Problem 102 102
No Device Output 98 98
Audible Prompt/Feedback Problem 98 98
Gas Output Problem 94 94
Leak/Splash 86 86
Defective Component 84 84
Decrease in Pressure 82 82
Increase in Pressure 78 78
Device Alarm System 71 71
Intermittent Loss of Power 60 60
Unexpected Shutdown 55 55
No Flow 51 51
Erratic or Intermittent Display 51 51
Free or Unrestricted Flow 51 51
Improper Flow or Infusion 50 50
Defective Device 49 49
Infusion or Flow Problem 47 47
Insufficient Flow or Under Infusion 46 46
Circuit Failure 46 46
Insufficient Information 45 45
Inflation Problem 44 44
Noise, Audible 44 44
Fail-Safe Did Not Operate 42 42
Communication or Transmission Problem 41 41
Incorrect, Inadequate or Imprecise Result or Readings 38 38
Excess Flow or Over-Infusion 35 35
Material Fragmentation 34 34
Inaccurate Flow Rate 33 33
Detachment of Device or Device Component 29 29
Key or Button Unresponsive/not Working 26 26
Mechanical Problem 25 25
Complete Loss of Power 21 21
Defective Alarm 19 19
Restricted Flow rate 19 19
Therapeutic or Diagnostic Output Failure 18 18
Connection Problem 17 17
Contamination 17 17
Backflow 16 16
Component Missing 14 14

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3026 3026
No Consequences Or Impact To Patient 337 337
Air Embolism 145 145
No Known Impact Or Consequence To Patient 94 94
Insufficient Information 89 89
Injury 31 31
Bradycardia 26 26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 26 26
Cardiac Arrest 25 25
No Patient Involvement 24 24
No Code Available 18 18
Pneumothorax 14 14
Infiltration into Tissue 12 12
Hypothermia 10 10
Hemorrhage/Bleeding 10 10
Embolism/Embolus 10 10
Abdominal Distention 8 8
Unspecified Respiratory Problem 7 7
Burn(s) 7 7
Bowel Perforation 7 7
Abdominal Pain 7 7
Low Blood Pressure/ Hypotension 6 6
Dyspnea 6 6
Low Oxygen Saturation 5 5
Pulmonary Emphysema 5 5
Perforation 5 5
Unspecified Tissue Injury 5 5
Stroke/CVA 5 5
Swelling 5 5
Patient Problem/Medical Problem 5 5
Pain 5 5
Burn, Thermal 4 4
Death 4 4
Foreign Body In Patient 4 4
Laceration(s) 4 4
Ischemia Stroke 3 3
Swelling/ Edema 3 3
Tachycardia 3 3
Arrhythmia 3 3
Test Result 2 2
Skin Disorders 2 2
Respiratory Insufficiency 2 2
Respiratory Arrest 2 2
Electrolyte Imbalance 2 2
Fever 2 2
Paralysis 2 2
Hypoxia 2 2
Loss Of Pulse 2 2
Hyperthermia 2 2
Caustic/Chemical Burns 2 2

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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