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TPLC
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show TPLC since
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Device
lavage, jet
Product Code
FQH
Regulation Number
880.5475
Device Class
2
Premarket Reviews
Manufacturer
Decision
BECTON, DICKINSON AND COMPANY
SUBSTANTIALLY EQUIVALENT
1
INOPRO INC
SUBSTANTIALLY EQUIVALENT
1
IRRIMAX CORPORATION
SUBSTANTIALLY EQUIVALENT
2
NEXT SCIENCE, LLC
SUBSTANTIALLY EQUIVALENT
1
ORTHOPHOR, LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
243
243
2018
317
317
2019
328
353
2020
393
427
2021
398
450
2022
94
112
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
155
163
No Flow
111
111
Battery Problem
94
94
Fluid Leak
93
157
Expulsion
88
88
Difficult to Insert
79
79
Leak/Splash
68
68
Overheating of Device
65
65
Failure to Prime
63
63
Device Contaminated During Manufacture or Shipping
61
61
Delivered as Unsterile Product
58
110
Mechanical Problem
57
57
Disconnection
57
57
Break
56
56
Biocompatibility
53
53
Failure to Power Up
51
51
Improper Flow or Infusion
45
45
Connection Problem
43
43
Defective Device
39
39
Corroded
34
34
Smoking
33
33
Appropriate Term/Code Not Available
32
32
Defective Component
30
30
Electrical /Electronic Property Problem
29
29
Inability to Irrigate
27
27
Infusion or Flow Problem
26
26
Noise, Audible
24
24
Device Contamination with Chemical or Other Material
21
21
Material Rupture
21
21
Pressure Problem
20
20
Device Operates Differently Than Expected
19
19
Loose or Intermittent Connection
19
19
Fracture
18
23
Power Problem
18
18
Adverse Event Without Identified Device or Use Problem
16
16
Melted
14
14
Electrical Power Problem
13
13
Material Deformation
13
13
Component Missing
13
13
Manufacturing, Packaging or Shipping Problem
11
11
Positioning Problem
11
11
Inaccurate Flow Rate
11
11
Device Emits Odor
10
10
Vibration
10
10
Protective Measures Problem
10
10
Material Integrity Problem
10
10
Inaccurate Delivery
10
10
Activation, Positioning or SeparationProblem
10
10
No Pressure
9
9
No Apparent Adverse Event
8
8
Suction Problem
8
8
Decrease in Pressure
8
8
Burst Container or Vessel
8
8
Excessive Heating
8
8
Material Split, Cut or Torn
7
7
Device Alarm System
7
7
Disassembly
7
7
Insufficient Information
7
7
Temperature Problem
6
6
Device Dislodged or Dislocated
6
6
Obstruction of Flow
6
6
Structural Problem
6
6
Loss of Power
6
6
Material Separation
5
5
Material Frayed
5
5
Difficult to Remove
5
5
Failure to Deliver
5
5
Material Twisted/Bent
5
5
Mechanical Jam
4
4
Output Problem
4
4
Malposition of Device
4
4
Failure to Cut
4
4
Detachment Of Device Component
4
4
Shipping Damage or Problem
4
4
Insufficient Flow or Under Infusion
4
4
Device Damaged Prior to Use
3
3
Device Inoperable
3
3
Circuit Failure
3
3
Premature Discharge of Battery
3
3
Gas Output Problem
3
3
Fire
3
3
No Display/Image
3
3
Device Markings/Labelling Problem
3
3
Sparking
3
3
Activation Failure
3
3
Communication or Transmission Problem
3
3
Electrical Shorting
3
3
Explosion
3
3
Patient Device Interaction Problem
2
2
Component Misassembled
2
2
Separation Problem
2
2
Intermittent Loss of Power
2
2
Therapeutic or Diagnostic Output Failure
2
2
Device Displays Incorrect Message
2
2
Contamination /Decontamination Problem
2
2
Display or Visual Feedback Problem
2
2
Labelling, Instructions for Use or Training Problem
2
2
Defective Alarm
2
2
Thermal Decomposition of Device
2
2
Crack
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
600
644
No Clinical Signs, Symptoms or Conditions
599
677
No Known Impact Or Consequence To Patient
362
368
No Patient Involvement
214
244
Foreign Body In Patient
33
33
Insufficient Information
24
24
No Information
19
19
No Code Available
17
17
Injury
12
12
Device Embedded In Tissue or Plaque
5
5
Not Applicable
4
4
Unspecified Infection
3
3
Necrosis
3
3
Seizures
1
1
Skin Discoloration
1
1
Sprain
1
1
Tissue Damage
1
1
Transient Ischemic Attack
1
1
Burning Sensation
1
1
Arrhythmia
1
1
Bruise/Contusion
1
1
Death
1
1
Non specific EKG/ECG Changes
1
1
Eye Injury
1
1
Hematoma
1
1
Hypersensitivity/Allergic reaction
1
1
High Blood Pressure/ Hypertension
1
1
Fluid Discharge
1
1
Arthralgia
1
1
Joint Swelling
1
1
Post Operative Wound Infection
1
1
Blister
1
1
Reaction to Medicinal Component of Device
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
IrriMAX Corporation
II
Oct-24-2019
2
Maquet Cardiovascular, LLC
II
Mar-07-2019
3
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
II
Nov-20-2018
4
Stryker Instruments Div. of Stryker Corporation
II
Mar-28-2018
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