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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
BUFFALO FILTER, LLC
  SUBSTANTIALLY EQUIVALENT 1
CARDIA INNOVATION AB
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
CORE ACCESS SURGICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
GRI MEDICAL AND ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG OPTOMEDIC TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU T.K MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GYNETECH PTY. LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU KANGJI MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HIPPOKRATEC GMBH
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPY-AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 2
LEXION MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 2
LEXION MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 9
MEDLINE, INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NORTHGATE TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
PALLIARE LTD.
  SUBSTANTIALLY EQUIVALENT 3
PREMIUM MEDICAL TECHNOLOGY LLC
  SUBSTANTIALLY EQUIVALENT 1
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOPRO - ACTEON GROUP
  SUBSTANTIALLY EQUIVALENT 1
SURGIQUEST, INC.
  SUBSTANTIALLY EQUIVALENT 3
SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TAUTONA GROUP RESEARCH & DEVELOPMENT, CO. LLC
  SUBSTANTIALLY EQUIVALENT 1
TEMED
  SUBSTANTIALLY EQUIVALENT 1
TIANJIN UWELL MEDICAL DEVICE MANUFACTURING CO.LTD.
  SUBSTANTIALLY EQUIVALENT 1
UNIMAX MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNIMICRO MEDICAL SYSTEMS (SHENZHEN) CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
W.O.M WORLD OF MEDICINE GMBH
  SUBSTANTIALLY EQUIVALENT 2
W.O.M. WORLD OF MEDICINE GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 43 43
2015 30 30
2016 72 72
2017 68 68
2018 97 97
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 342 342
Electrical /Electronic Property Problem 254 254
No Display/Image 226 226
Adverse Event Without Identified Device or Use Problem 207 207
Failure to Power Up 194 194
Display or Visual Feedback Problem 167 167
Break 128 128
Gas/Air Leak 126 126
Loss of Power 104 104
Power Problem 94 94
Insufficient Information 80 80
Output Problem 76 76
Increase in Pressure 70 70
Device Alarm System 67 67
Decrease in Pressure 66 66
Gas Output Problem 64 64
Audible Prompt/Feedback Problem 61 61
Device Operates Differently Than Expected 59 59
No Visual Prompts/Feedback 57 57
Defective Component 56 56
No Flow 50 50
Defective Device 48 48
Improper Flow or Infusion 48 48
Infusion or Flow Problem 47 47
Intermittent Loss of Power 46 46
Unexpected Shutdown 46 46
Erratic or Intermittent Display 44 44
Leak/Splash 41 41
No Device Output 41 41
Noise, Audible 39 39
Free or Unrestricted Flow 38 38
Communication or Transmission Problem 37 37
Material Fragmentation 36 36
Circuit Failure 35 35
Inflation Problem 34 34
Incorrect, Inadequate or Imprecise Result or Readings 34 34
Fail-Safe Did Not Operate 34 34
Insufficient Flow or Under Infusion 33 33
Detachment of Device or Device Component 30 30
Inaccurate Flow Rate 28 28
Mechanical Problem 23 23
Device Contamination with Chemical or Other Material 22 22
Excess Flow or Over-Infusion 20 20
Connection Problem 19 19
Tear, Rip or Hole in Device Packaging 19 19
Key or Button Unresponsive/not Working 19 19
Therapeutic or Diagnostic Output Failure 18 18
Device Displays Incorrect Message 18 18
Restricted Flow rate 17 17
Contamination 17 17
Backflow 16 16
Complete Loss of Power 16 16
Defective Alarm 15 15
Disconnection 15 15
Fluid/Blood Leak 13 13
Overheating of Device 12 12
Appropriate Term/Code Not Available 12 12
No Apparent Adverse Event 12 12
No Pressure 12 12
Patient Device Interaction Problem 10 10
Nonstandard Device 10 10
Crack 10 10
Device Reprocessing Problem 10 10
Electrical Power Problem 10 10
Failure to Auto Stop 9 9
Device Sensing Problem 9 9
Use of Device Problem 9 9
Component Missing 8 8
Contamination /Decontamination Problem 8 8
Thermal Decomposition of Device 8 8
No Audible Alarm 8 8
Corroded 8 8
Energy Output Problem 8 8
Smoking 7 7
Failure to Clean Adequately 7 7
Application Program Problem 6 6
Material Deformation 6 6
Image Display Error/Artifact 6 6
Detachment Of Device Component 6 6
False Alarm 5 5
Unintended Collision 5 5
Failure to Shut Off 5 5
Inaccurate Delivery 5 5
Incomplete or Inadequate Connection 5 5
Packaging Problem 5 5
Protective Measures Problem 4 4
Ambient Noise Problem 4 4
Material Separation 4 4
Improper or Incorrect Procedure or Method 4 4
Suction Problem 4 4
Device Inoperable 4 4
Unable to Obtain Readings 4 4
Delivered as Unsterile Product 4 4
Misconnection 4 4
Loose or Intermittent Connection 4 4
Intermittent Continuity 4 4
Display Difficult to Read 3 3
Fracture 3 3
Increase in Suction 3 3
Self-Activation or Keying 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2214 2214
No Consequences Or Impact To Patient 379 379
No Known Impact Or Consequence To Patient 239 239
Insufficient Information 85 85
Air Embolism 42 42
Injury 36 36
No Code Available 34 34
No Patient Involvement 29 29
Bradycardia 26 26
Cardiac Arrest 26 26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 24 24
Pneumothorax 15 15
Burn(s) 13 13
No Information 13 13
Abdominal Distention 12 12
Infiltration into Tissue 12 12
Hemorrhage/Bleeding 11 11
Bowel Perforation 10 10
Pulmonary Emphysema 9 9
Death 9 9
Perforation 8 8
Laceration(s) 7 7
Swelling 7 7
Abdominal Pain 7 7
Burn, Thermal 7 7
Unspecified Respiratory Problem 7 7
Embolism/Embolus 6 6
Low Blood Pressure/ Hypotension 6 6
Pain 6 6
Low Oxygen Saturation 5 5
Inflammation 5 5
Hypoxia 5 5
Stroke/CVA 5 5
Unspecified Tissue Injury 5 5
Patient Problem/Medical Problem 5 5
Partial thickness (Second Degree) Burn 5 5
Foreign Body In Patient 4 4
Loss Of Pulse 4 4
Contusion 4 4
Cardiopulmonary Arrest 4 4
Dyspnea 4 4
High Blood Pressure/ Hypertension 4 4
Extravasation 4 4
Hypothermia 3 3
Arrhythmia 3 3
Complaint, Ill-Defined 3 3
Tachycardia 3 3
Test Result 3 3
Swelling/ Edema 3 3
Skin Disorders 2 2
Respiratory Arrest 2 2
Respiratory Insufficiency 2 2
Blood Loss 2 2
Caustic/Chemical Burns 2 2
Tissue Damage 2 2
Rash 2 2
Paralysis 2 2
Electrolyte Imbalance 2 2
Unspecified Infection 2 2
Erythema 2 2
Fever 1 1
Fistula 1 1
Hematoma 1 1
Keratitis 1 1
Hypoventilation 1 1
Hypovolemic Shock 1 1
Atrial Fibrillation 1 1
Abnormal Blood Gases 1 1
Airway Obstruction 1 1
Edema 1 1
Embolism 1 1
Embolus 1 1
Cyanosis 1 1
Pulmonary Edema 1 1
Respiratory Acidosis 1 1
Respiratory Failure 1 1
Increased Respiratory Rate 1 1
Low Cardiac Output 1 1
Sudden Cardiac Death 1 1
Heart Failure 1 1
Rupture 1 1
Brain Injury 1 1
Hernia 1 1
Peritonitis 1 1
Stenosis 1 1
Distress 1 1
Peritoneal Laceration(s) 1 1
Pneumonia 1 1
Liver Laceration(s) 1 1
Myocardial Infarction 1 1
Occlusion 1 1
Respiratory Distress 1 1
Scar Tissue 1 1
Shock 1 1
Great Vessel Perforation 1 1
Forced Expiratory Volume Increased 1 1
Choking 1 1
Chemical Exposure 1 1
Not Applicable 1 1
Tissue Breakdown 1 1

Recalls
Manufacturer Recall Class Date Posted
1 EXP Pharmaceutical Services Corp II Jul-24-2015
2 Northgate Technologies, Inc. II Feb-24-2021
3 Northgate Technologies, Inc. II Dec-21-2016
4 Olympus Corporation of the Americas II Mar-25-2024
5 Olympus Corporation of the Americas I Oct-18-2023
6 Richard Wolf GmbH II Jul-27-2020
7 Richard Wolf GmbH II May-14-2018
8 Stryker Corporation II Jun-04-2019
9 Stryker Endoscopy II Apr-25-2016
10 Stryker Endoscopy II Mar-23-2010
11 WOM World of Medicine AG II Nov-27-2018
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