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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 784 784

Device Problems MDRs with this Device Problem Events in those MDRs
Pressure Problem 390 390
No Display/Image 281 281
Electrical /Electronic Property Problem 263 263
Failure to Power Up 225 225
Adverse Event Without Identified Device or Use Problem 220 220
Display or Visual Feedback Problem 176 176
Gas/Air Leak 165 165
Break 142 142
Loss of Power 136 136
Output Problem 100 100
Power Problem 99 99
No Visual Prompts/Feedback 94 94
Audible Prompt/Feedback Problem 88 88
Gas Output Problem 88 88
Increase in Pressure 82 82
Insufficient Information 81 81
Leak/Splash 74 74
Decrease in Pressure 72 72
Device Alarm System 71 71
Defective Component 71 71
No Device Output 68 68
Device Operates Differently Than Expected 59 59
No Flow 55 55
Intermittent Loss of Power 55 55
Improper Flow or Infusion 54 54
Unexpected Shutdown 52 52
Infusion or Flow Problem 51 51
Erratic or Intermittent Display 51 51
Defective Device 49 49
Inflation Problem 48 48
Noise, Audible 45 45
Free or Unrestricted Flow 45 45
Circuit Failure 42 42
Insufficient Flow or Under Infusion 40 40
Communication or Transmission Problem 40 40
Material Fragmentation 36 36
Incorrect, Inadequate or Imprecise Result or Readings 36 36
Fail-Safe Did Not Operate 35 35
Detachment of Device or Device Component 34 34
Inaccurate Flow Rate 30 30
Excess Flow or Over-Infusion 27 27
Mechanical Problem 25 25
Device Contamination with Chemical or Other Material 22 22
Connection Problem 20 20
Key or Button Unresponsive/not Working 20 20
Device Displays Incorrect Message 20 20
Complete Loss of Power 20 20
Tear, Rip or Hole in Device Packaging 19 19
Therapeutic or Diagnostic Output Failure 18 18
Contamination 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2718 2718
No Consequences Or Impact To Patient 379 379
No Known Impact Or Consequence To Patient 239 239
Insufficient Information 89 89
Air Embolism 45 45
Injury 36 36
No Code Available 34 34
Bradycardia 29 29
No Patient Involvement 29 29
Cardiac Arrest 28 28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 25 25
Pneumothorax 20 20
Burn(s) 13 13
No Information 13 13
Abdominal Distention 13 13
Hemorrhage/Bleeding 12 12
Infiltration into Tissue 12 12
Bowel Perforation 10 10
Death 9 9
Pulmonary Emphysema 9 9
Abdominal Pain 8 8
Perforation 8 8
Laceration(s) 7 7
Unspecified Respiratory Problem 7 7
Swelling 7 7
Burn, Thermal 7 7
Low Blood Pressure/ Hypotension 7 7
Embolism/Embolus 7 7
Pain 6 6
Inflammation 5 5
Low Oxygen Saturation 5 5
Unspecified Tissue Injury 5 5
Hypoxia 5 5
Stroke/CVA 5 5
Dyspnea 5 5
Patient Problem/Medical Problem 5 5
Partial thickness (Second Degree) Burn 5 5
Extravasation 4 4
High Blood Pressure/ Hypertension 4 4
Contusion 4 4
Loss Of Pulse 4 4
Foreign Body In Patient 4 4
Cardiopulmonary Arrest 4 4
Swelling/ Edema 3 3
Tachycardia 3 3
Test Result 3 3
Electrolyte Imbalance 3 3
Complaint, Ill-Defined 3 3
Arrhythmia 3 3
Hypothermia 3 3

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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