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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
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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