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TPLC
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Device
insufflator, laparoscopic
Product Code
HIF
Regulation Number
884.1730
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
No Information
13
13
Burn(s)
13
13
Infiltration into Tissue
12
12
Abdominal Distention
12
12
Hemorrhage/Bleeding
11
11
Bowel Perforation
10
10
Pulmonary Emphysema
9
9
Death
9
9
Perforation
8
8
Burn, Thermal
7
7
Abdominal Pain
7
7
Swelling
7
7
Unspecified Respiratory Problem
7
7
Laceration(s)
7
7
Embolism/Embolus
6
6
Pain
6
6
Low Blood Pressure/ Hypotension
6
6
Low Oxygen Saturation
5
5
Hypoxia
5
5
Patient Problem/Medical Problem
5
5
Partial thickness (Second Degree) Burn
5
5
Inflammation
5
5
Stroke/CVA
5
5
Unspecified Tissue Injury
5
5
Contusion
4
4
Foreign Body In Patient
4
4
Extravasation
4
4
Cardiopulmonary Arrest
4
4
High Blood Pressure/ Hypertension
4
4
Loss Of Pulse
4
4
Dyspnea
4
4
Swelling/ Edema
3
3
Hypothermia
3
3
Tachycardia
3
3
Test Result
3
3
Complaint, Ill-Defined
3
3
Arrhythmia
3
3
Respiratory Arrest
2
2
Tissue Damage
2
2
Electrolyte Imbalance
2
2
Caustic/Chemical Burns
2
2
Rash
2
2
Erythema
2
2
Blood Loss
2
2
Unspecified Infection
2
2
Paralysis
2
2
Respiratory Insufficiency
2
2
Skin Disorders
2
2
Peritoneal Laceration(s)
1
1
Myocardial Infarction
1
1
Cardiovascular Insufficiency
1
1
Edema
1
1
Great Vessel Perforation
1
1
Increased Respiratory Rate
1
1
Pulmonary Edema
1
1
Hypoventilation
1
1
Respiratory Acidosis
1
1
Occlusion
1
1
Hematoma
1
1
Peritonitis
1
1
Respiratory Failure
1
1
Pneumonia
1
1
Embolism
1
1
Fistula
1
1
Distress
1
1
Atrial Fibrillation
1
1
Keratitis
1
1
Embolus
1
1
Low Cardiac Output
1
1
Subcutaneous Nodule
1
1
Fever
1
1
Unspecified Vascular Problem
1
1
Rupture
1
1
Hernia
1
1
Hypovolemic Shock
1
1
Sudden Cardiac Death
1
1
Airway Obstruction
1
1
Choking
1
1
Forced Expiratory Volume Increased
1
1
Ischemia Stroke
1
1
Tissue Breakdown
1
1
Stenosis
1
1
Scar Tissue
1
1
Respiratory Distress
1
1
Abnormal Blood Gases
1
1
Not Applicable
1
1
Brain Injury
1
1
Heart Failure
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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