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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
FREYJA HEALTHCARE, LLC
  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 4
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 328 328

Device Problems MDRs with this Device Problem Events in those MDRs
Pressure Problem 349 349
Electrical /Electronic Property Problem 254 254
No Display/Image 236 236
Adverse Event Without Identified Device or Use Problem 207 207
Failure to Power Up 202 202
Display or Visual Feedback Problem 169 169
Gas/Air Leak 131 131
Break 129 129
Loss of Power 109 109
Power Problem 95 95
Insufficient Information 81 81
Output Problem 76 76
Increase in Pressure 73 73
Decrease in Pressure 68 68
Device Alarm System 68 68
Gas Output Problem 66 66
Audible Prompt/Feedback Problem 66 66
Device Operates Differently Than Expected 59 59
Defective Component 58 58
No Visual Prompts/Feedback 58 58
No Flow 50 50
Defective Device 48 48
Improper Flow or Infusion 48 48
Infusion or Flow Problem 47 47
Intermittent Loss of Power 47 47
Unexpected Shutdown 46 46
Leak/Splash 44 44
Erratic or Intermittent Display 44 44
No Device Output 43 43
Free or Unrestricted Flow 40 40
Noise, Audible 39 39
Communication or Transmission Problem 37 37
Material Fragmentation 36 36
Inflation Problem 35 35
Circuit Failure 35 35
Fail-Safe Did Not Operate 35 35
Incorrect, Inadequate or Imprecise Result or Readings 34 34
Insufficient Flow or Under Infusion 34 34
Detachment of Device or Device Component 31 31
Inaccurate Flow Rate 28 28
Mechanical Problem 23 23
Excess Flow or Over-Infusion 22 22
Device Contamination with Chemical or Other Material 22 22
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
Defective Alarm 17 17
Contamination 17 17
Backflow 16 16
Complete Loss of Power 16 16
Disconnection 15 15
Fluid/Blood Leak 13 13
Overheating of Device 12 12
No Apparent Adverse Event 12 12
Appropriate Term/Code Not Available 12 12
No Pressure 12 12
Crack 11 11
Electrical Power Problem 11 11
Failure to Auto Stop 10 10
Device Reprocessing Problem 10 10
Nonstandard Device 10 10
Patient Device Interaction Problem 10 10
Device Sensing Problem 9 9
Use of Device Problem 9 9
Component Missing 8 8
Contamination /Decontamination Problem 8 8
Energy Output Problem 8 8
Thermal Decomposition of Device 8 8
No Audible Alarm 8 8
Corroded 8 8
Material Deformation 7 7
Smoking 7 7
Failure to Clean Adequately 7 7
Incomplete or Inadequate Connection 6 6
Application Program Problem 6 6
Detachment Of Device Component 6 6
Image Display Error/Artifact 6 6
Loose or Intermittent Connection 6 6
Unintended Collision 5 5
False Alarm 5 5
Inaccurate Delivery 5 5
Failure to Shut Off 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
Intermittent Continuity 4 4
Unable to Obtain Readings 4 4
Delivered as Unsterile Product 4 4
Misconnection 4 4
Poor Quality Image 3 3
Fracture 3 3
Display Difficult to Read 3 3
Degraded 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2284 2284
No Consequences Or Impact To Patient 379 379
No Known Impact Or Consequence To Patient 239 239
Insufficient Information 86 86
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 25 25
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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