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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
GRI MEDICAL AND ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU T.K MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LEXION MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
PALLIARE LTD.
  SUBSTANTIALLY EQUIVALENT 3
TEMED
  SUBSTANTIALLY EQUIVALENT 1
W.O.M. WORLD OF MEDICINE GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 97 97
2019 128 128
2020 360 360
2021 654 654
2022 667 667
2023 105 105

Device Problems MDRs with this Device Problem Events in those MDRs
Electrical /Electronic Property Problem 219 219
Pressure Problem 159 159
Failure to Power Up 150 150
No Display/Image 140 140
Adverse Event Without Identified Device or Use Problem 136 136
Display or Visual Feedback Problem 112 112
Break 100 100
Gas/Air Leak 71 71
Power Problem 60 60
Output Problem 50 50
Decrease in Pressure 50 50
Increase in Pressure 48 48
Loss of Power 45 45
Improper Flow or Infusion 43 43
Infusion or Flow Problem 42 42
Defective Device 41 41
No Flow 39 39
Insufficient Information 39 39
Erratic or Intermittent Display 36 36
Material Fragmentation 36 36
Unexpected Shutdown 33 33
Noise, Audible 30 30
Gas Output Problem 28 28
Device Alarm System 28 28
Leak/Splash 27 27
Circuit Failure 26 26
Intermittent Loss of Power 24 24
Detachment of Device or Device Component 23 23
Insufficient Flow or Under Infusion 22 22
Defective Component 22 22
Inflation Problem 21 21
Mechanical Problem 19 19
Therapeutic or Diagnostic Output Failure 18 18
Device Operates Differently Than Expected 17 17
Communication or Transmission Problem 16 16
Contamination 16 16
Backflow 16 16
Device Contamination with Chemical or Other Material 15 15
Tear, Rip or Hole in Device Packaging 14 14
Inaccurate Flow Rate 14 14
Incorrect, Inadequate or Imprecise Result or Readings 14 14
Restricted Flow rate 13 13
Connection Problem 13 13
No Device Output 12 12
Disconnection 12 12
Appropriate Term/Code Not Available 11 11
No Apparent Adverse Event 11 11
Patient Device Interaction Problem 10 10
Crack 10 10
Nonstandard Device 10 10
Key or Button Unresponsive/not Working 10 10
Device Reprocessing Problem 9 9
Defective Alarm 9 9
Fluid/Blood Leak 9 9
Complete Loss of Power 9 9
Device Displays Incorrect Message 8 8
Excess Flow or Over-Infusion 8 8
Energy Output Problem 8 8
Overheating of Device 7 7
Thermal Decomposition of Device 7 7
Contamination /Decontamination Problem 7 7
No Pressure 7 7
Failure to Auto Stop 6 6
Device Sensing Problem 6 6
Application Program Problem 6 6
Use of Device Problem 6 6
Audible Prompt/Feedback Problem 6 6
No Visual Prompts/Feedback 6 6
Unintended Collision 5 5
False Alarm 5 5
Inaccurate Delivery 5 5
Component Missing 5 5
Material Deformation 5 5
Ambient Noise Problem 4 4
Electrical Power Problem 4 4
Image Display Error/Artifact 4 4
Corroded 4 4
Fracture 3 3
No Audible Alarm 3 3
Detachment Of Device Component 3 3
Delivered as Unsterile Product 3 3
Material Separation 3 3
Smoking 3 3
Suction Problem 3 3
Obstruction of Flow 3 3
Unintended Movement 3 3
Protective Measures Problem 3 3
Failure to Clean Adequately 3 3
Activation Problem 2 2
Packaging Problem 2 2
Material Split, Cut or Torn 2 2
Material Integrity Problem 2 2
Mechanical Jam 2 2
Medical Gas Supply Problem 2 2
Optical Problem 2 2
Calibration Problem 2 2
Device Dislodged or Dislocated 2 2
Electrical Shorting 2 2
Failure to Shut Off 2 2
Improper or Incorrect Procedure or Method 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1241 1241
No Consequences Or Impact To Patient 354 354
No Known Impact Or Consequence To Patient 143 143
Insufficient Information 75 75
Injury 34 34
No Patient Involvement 28 28
No Code Available 25 25
Air Embolism 25 25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Bradycardia 17 17
Pneumothorax 11 11
Infiltration into Tissue 10 10
Cardiac Arrest 10 10
Hemorrhage/Bleeding 8 8
Burn(s) 5 5
Abdominal Pain 5 5
Low Blood Pressure/ Hypotension 5 5
Pain 5 5
Perforation 5 5
Swelling 5 5
Embolism/Embolus 5 5
Patient Problem/Medical Problem 5 5
Foreign Body In Patient 4 4
Abdominal Distention 4 4
Burn, Thermal 4 4
Partial thickness (Second Degree) Burn 4 4
No Information 4 4
Unspecified Tissue Injury 4 4
Death 4 4
Dyspnea 4 4
Pulmonary Emphysema 3 3
Stroke/CVA 3 3
Swelling/ Edema 3 3
Low Oxygen Saturation 3 3
Bowel Perforation 3 3
Unspecified Infection 2 2
Caustic/Chemical Burns 2 2
Loss Of Pulse 2 2
Unspecified Respiratory Problem 2 2
Skin Disorders 2 2
Test Result 2 2
Respiratory Arrest 2 2
Arrhythmia 2 2
Laceration(s) 2 2
Liver Laceration(s) 1 1
Hypothermia 1 1
Pneumonia 1 1
Paralysis 1 1
Great Vessel Perforation 1 1
Electrolyte Imbalance 1 1
Heart Failure 1 1
Stenosis 1 1
Respiratory Distress 1 1
Scar Tissue 1 1
Shock 1 1
Abnormal Blood Gases 1 1
Cardiopulmonary Arrest 1 1
Cyanosis 1 1
High Blood Pressure/ Hypertension 1 1
Fever 1 1
Fistula 1 1
Respiratory Insufficiency 1 1
Cardiovascular Insufficiency 1 1
Convulsion/Seizure 1 1
Chemical Exposure 1 1
Respiratory Acidosis 1 1
Low Cardiac Output 1 1
Sudden Cardiac Death 1 1
Forced Expiratory Volume Increased 1 1
Choking 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Northgate Technologies, Inc. II Feb-24-2021
2 Richard Wolf GmbH II Jul-27-2020
3 Richard Wolf GmbH II May-14-2018
4 Stryker Corporation II Jun-04-2019
5 WOM World of Medicine AG II Nov-27-2018
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