Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
insufflator, laparoscopic
Product Code
HIF
Regulation Number
884.1730
Device Class
2
Premarket Reviews
Manufacturer
Decision
CONMED CORPORATION
SUBSTANTIALLY EQUIVALENT
3
CORE ACCESS SURGICAL TECHNOLOGIES, INC.
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
3
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 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
256
256
Device Problems
MDRs with this Device Problem
Events in those MDRs
Pressure Problem
325
325
Electrical /Electronic Property Problem
253
253
No Display/Image
226
226
Failure to Power Up
194
194
Display or Visual Feedback Problem
167
167
Adverse Event Without Identified Device or Use Problem
165
165
Gas/Air Leak
124
124
Break
110
110
Loss of Power
100
100
Power Problem
93
93
Output Problem
76
76
Decrease in Pressure
66
66
Device Alarm System
65
65
Gas Output Problem
64
64
Increase in Pressure
62
62
Audible Prompt/Feedback Problem
61
61
No Visual Prompts/Feedback
57
57
Defective Component
55
55
Defective Device
46
46
Intermittent Loss of Power
46
46
Insufficient Information
44
44
Erratic or Intermittent Display
44
44
No Flow
43
43
Unexpected Shutdown
43
43
Improper Flow or Infusion
42
42
Infusion or Flow Problem
41
41
No Device Output
41
41
Free or Unrestricted Flow
38
38
Communication or Transmission Problem
37
37
Leak/Splash
37
37
Noise, Audible
36
36
Incorrect, Inadequate or Imprecise Result or Readings
34
34
Material Fragmentation
34
34
Circuit Failure
34
34
Fail-Safe Did Not Operate
34
34
Insufficient Flow or Under Infusion
32
32
Inflation Problem
28
28
Inaccurate Flow Rate
27
27
Detachment of Device or Device Component
25
25
Mechanical Problem
21
21
Excess Flow or Over-Infusion
19
19
Key or Button Unresponsive/not Working
19
19
Therapeutic or Diagnostic Output Failure
18
18
Restricted Flow rate
17
17
Contamination
17
17
Backflow
16
16
Connection Problem
16
16
Complete Loss of Power
16
16
Defective Alarm
15
15
Disconnection
13
13
Fluid/Blood Leak
12
12
Tear, Rip or Hole in Device Packaging
12
12
No Apparent Adverse Event
12
12
No Pressure
12
12
Patient Device Interaction Problem
10
10
Electrical Power Problem
10
10
Device Reprocessing Problem
10
10
Nonstandard Device
10
10
Crack
9
9
Appropriate Term/Code Not Available
9
9
Failure to Auto Stop
8
8
Device Contamination with Chemical or Other Material
8
8
Device Sensing Problem
8
8
Component Missing
8
8
Corroded
8
8
Overheating of Device
8
8
Energy Output Problem
8
8
Failure to Clean Adequately
7
7
Use of Device Problem
6
6
Smoking
6
6
Device Displays Incorrect Message
6
6
Application Program Problem
6
6
Contamination /Decontamination Problem
6
6
Material Deformation
6
6
Failure to Shut Off
5
5
Inaccurate Delivery
5
5
Unintended Collision
5
5
Image Display Error/Artifact
5
5
Thermal Decomposition of Device
5
5
False Alarm
5
5
Incomplete or Inadequate Connection
5
5
No Audible Alarm
4
4
Intermittent Continuity
4
4
Loose or Intermittent Connection
4
4
Ambient Noise Problem
4
4
Suction Problem
4
4
Protective Measures Problem
4
4
Material Split, Cut or Torn
3
3
Optical Problem
3
3
Mechanical Jam
3
3
Medical Gas Supply Problem
3
3
Obstruction of Flow
3
3
Misconnection
3
3
Increase in Suction
3
3
Failure to Sense
3
3
Unable to Obtain Readings
3
3
Display Difficult to Read
3
3
Activation Problem
3
3
Use of Incorrect Control/Treatment Settings
2
2
Failure to Deliver Energy
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2212
2212
No Consequences Or Impact To Patient
337
337
No Known Impact Or Consequence To Patient
94
94
Insufficient Information
85
85
Air Embolism
41
41
Injury
31
31
No Patient Involvement
24
24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
24
24
Bradycardia
23
23
Cardiac Arrest
21
21
No Code Available
18
18
Infiltration into Tissue
12
12
Hemorrhage/Bleeding
9
9
Pneumothorax
8
8
Abdominal Distention
7
7
Burn(s)
7
7
Unspecified Respiratory Problem
7
7
Abdominal Pain
6
6
Embolism/Embolus
6
6
Low Oxygen Saturation
5
5
Pulmonary Emphysema
5
5
Pain
5
5
Perforation
5
5
Swelling
5
5
Unspecified Tissue Injury
5
5
Patient Problem/Medical Problem
5
5
Low Blood Pressure/ Hypotension
4
4
Laceration(s)
4
4
Death
4
4
Dyspnea
4
4
Stroke/CVA
4
4
Burn, Thermal
4
4
Foreign Body In Patient
4
4
Bowel Perforation
3
3
Arrhythmia
3
3
Swelling/ Edema
3
3
Skin Disorders
2
2
Hypoxia
2
2
Unspecified Infection
2
2
Hypothermia
2
2
Paralysis
2
2
Partial thickness (Second Degree) Burn
2
2
Test Result
2
2
Respiratory Arrest
2
2
Respiratory Insufficiency
2
2
Caustic/Chemical Burns
2
2
Loss Of Pulse
2
2
Chemical Exposure
1
1
Respiratory Acidosis
1
1
Low Cardiac Output
1
1
Sudden Cardiac Death
1
1
Scar Tissue
1
1
Shock
1
1
Forced Expiratory Volume Increased
1
1
Choking
1
1
Rupture
1
1
Brain Injury
1
1
Stenosis
1
1
Convulsion/Seizure
1
1
Ischemia Stroke
1
1
Unspecified Vascular Problem
1
1
Asystole
1
1
Cardiovascular Insufficiency
1
1
No Information
1
1
Tissue Breakdown
1
1
Peritoneal Laceration(s)
1
1
Pneumonia
1
1
Tachycardia
1
1
Great Vessel Perforation
1
1
Electrolyte Imbalance
1
1
Hypovolemic Shock
1
1
High Blood Pressure/ Hypertension
1
1
Myocardial Infarction
1
1
Atrial Fibrillation
1
1
Abnormal Blood Gases
1
1
Airway Obstruction
1
1
Cyanosis
1
1
Cardiopulmonary Arrest
1
1
Fever
1
1
Fistula
1
1
Subcutaneous Nodule
1
1
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
-
-