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
table, operating-room, electrical
Product Code
GDC
Regulation Number
878.4960
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
64
64
2020
253
253
2021
259
259
2022
57
57
2023
62
62
2024
21
21
Device Problems
MDRs with this Device Problem
Events in those MDRs
Unstable
117
117
Unintended Movement
90
90
Physical Resistance/Sticking
78
78
Positioning Failure
51
51
Positioning Problem
47
47
Leak/Splash
37
37
Overheating of Device
28
28
Battery Problem
26
26
Material Too Rigid or Stiff
23
23
Fluid/Blood Leak
22
22
Mechanical Problem
21
21
Failure to Power Up
21
21
Mechanical Jam
21
21
Noise, Audible
20
20
No Apparent Adverse Event
16
16
Unintended System Motion
14
14
Decrease in Pressure
13
13
Break
12
12
Insufficient Information
11
11
Smoking
9
9
Key or Button Unresponsive/not Working
9
9
Operating System Becomes Nonfunctional
8
8
Use of Device Problem
7
7
Self-Activation or Keying
7
7
Fire
6
6
Failure to Charge
6
6
Device Fell
6
6
Material Deformation
5
5
Crack
5
5
Defective Component
5
5
Therapeutic or Diagnostic Output Failure
5
5
Device Slipped
4
4
Device Emits Odor
4
4
Fracture
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Power Problem
4
4
Pressure Problem
3
3
Output Problem
3
3
Appropriate Term/Code Not Available
3
3
Device Handling Problem
3
3
Failure to Align
3
3
Connection Problem
3
3
Detachment of Device or Device Component
3
3
Electrical /Electronic Property Problem
3
3
Difficult or Delayed Positioning
3
3
Loss of Power
3
3
Improper or Incorrect Procedure or Method
2
2
Loose or Intermittent Connection
2
2
Device Dislodged or Dislocated
2
2
Electrical Shorting
2
2
Failure of Device to Self-Test
2
2
Compatibility Problem
2
2
Sparking
2
2
Malposition of Device
2
2
Complete Loss of Power
2
2
Unintended Electrical Shock
1
1
Unexpected Shutdown
1
1
Activation Problem
1
1
Unclear Information
1
1
Activation Failure
1
1
Device Difficult to Maintain
1
1
Protective Measures Problem
1
1
Difficult or Delayed Activation
1
1
Defective Device
1
1
No Pressure
1
1
Moisture or Humidity Problem
1
1
Material Integrity Problem
1
1
Charging Problem
1
1
Component or Accessory Incompatibility
1
1
Incorrect Measurement
1
1
Loss of or Failure to Bond
1
1
Grounding Malfunction
1
1
Unintended Power Up
1
1
Collapse
1
1
Corroded
1
1
Device Damaged Prior to Use
1
1
Incomplete or Missing Packaging
1
1
Material Separation
1
1
Device Remains Activated
1
1
Lack of Effect
1
1
Material Split, Cut or Torn
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
419
419
No Patient Involvement
121
121
No Known Impact Or Consequence To Patient
117
117
No Information
12
12
No Consequences Or Impact To Patient
10
10
Insufficient Information
9
9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Laceration(s)
3
3
Nerve Damage
3
3
Injury
3
3
Numbness
3
3
Fall
2
2
Rupture
2
2
Abdominal Distention
2
2
Brain Injury
1
1
No Code Available
1
1
Heart Failure/Congestive Heart Failure
1
1
Hyperextension
1
1
Unspecified Tissue Injury
1
1
Bone Fracture(s)
1
1
Irritation
1
1
Liver Laceration(s)
1
1
Wound Dehiscence
1
1
Bruise/Contusion
1
1
Burn(s)
1
1
Cellulitis
1
1
Crushing Injury
1
1
Erythema
1
1
Burn, Thermal
1
1
Electric Shock
1
1
Pain
1
1
Perforation
1
1
Swelling
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Baxter Healthcare Corporation
II
Jul-07-2023
2
Baxter Healthcare Corporation
II
Nov-03-2022
3
Mizuho America, Inc.
II
Dec-14-2020
4
Mizuho OSI
II
Mar-23-2021
5
Skytron, LLC
II
Aug-28-2023
-
-