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TPLC
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show TPLC since
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Device
table, operating-room, ac-powered
Product Code
FQO
Regulation Number
878.4960
Device Class
1
Premarket Reviews
Manufacturer
Decision
MOON SURGICAL
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
118
118
2020
97
97
2021
102
102
2022
125
125
2023
191
191
2024
34
34
Device Problems
MDRs with this Device Problem
Events in those MDRs
Unintended Movement
145
145
Use of Device Problem
83
83
Detachment of Device or Device Component
51
51
Insufficient Information
48
48
Positioning Failure
42
42
Mechanical Problem
30
30
Improper or Incorrect Procedure or Method
29
29
Positioning Problem
24
24
Electromagnetic Interference
23
23
Device Fell
22
22
Adverse Event Without Identified Device or Use Problem
20
20
Unintended System Motion
20
20
Device Tipped Over
20
20
Communication or Transmission Problem
18
18
Smoking
18
18
Device Sensing Problem
16
16
Fluid/Blood Leak
15
15
Break
13
13
No Apparent Adverse Event
11
11
Circuit Failure
10
10
Battery Problem
10
10
Device Handling Problem
9
9
Electrical Shorting
8
8
Difficult or Delayed Positioning
8
8
Self-Activation or Keying
7
7
Sharp Edges
7
7
Key or Button Unresponsive/not Working
6
6
Noise, Audible
6
6
Patient Device Interaction Problem
6
6
Complete Loss of Power
6
6
Device Slipped
6
6
Structural Problem
6
6
Sparking
6
6
Charging Problem
6
6
Disconnection
6
6
Fracture
6
6
Fire
6
6
Device Emits Odor
6
6
Unintended Collision
6
6
Electrical /Electronic Property Problem
5
5
Physical Resistance/Sticking
5
5
Intermittent Communication Failure
5
5
Therapeutic or Diagnostic Output Failure
5
5
Protective Measures Problem
4
4
Mechanical Jam
4
4
Naturally Worn
4
4
Unintended Electrical Shock
4
4
Material Split, Cut or Torn
4
4
Overheating of Device
4
4
Loose or Intermittent Connection
4
4
Moisture Damage
4
4
Unstable
4
4
Defective Device
3
3
Electrical Overstress
3
3
Failure to Read Input Signal
3
3
Operating System Becomes Nonfunctional
3
3
Output Problem
3
3
Fail-Safe Problem
2
2
Human-Device Interface Problem
2
2
Power Problem
2
2
Material Twisted/Bent
2
2
Loss of Power
2
2
Device Difficult to Setup or Prepare
2
2
Connection Problem
2
2
Device Displays Incorrect Message
2
2
Leak/Splash
2
2
Material Fragmentation
2
2
Material Disintegration
2
2
Crack
2
2
Degraded
2
2
Failure to Conduct
2
2
Failure to Charge
2
2
Premature Discharge of Battery
2
2
Loss of or Failure to Bond
1
1
Intermittent Continuity
1
1
Corroded
1
1
Computer Software Problem
1
1
Accessory Incompatible
1
1
No Display/Image
1
1
Gas Output Problem
1
1
Labelling, Instructions for Use or Training Problem
1
1
Unintended Ejection
1
1
Melted
1
1
Migration or Expulsion of Device
1
1
Failure to Run on Battery
1
1
Malposition of Device
1
1
Calibration Problem
1
1
Activation, Positioning or Separation Problem
1
1
Device Damaged by Another Device
1
1
Device Unsafe to Use in Environment
1
1
Device Dislodged or Dislocated
1
1
Product Quality Problem
1
1
Failure to Recalibrate
1
1
Difficult to Remove
1
1
Failure to Sense
1
1
Inappropriate/Inadequate Shock/Stimulation
1
1
Failure to Align
1
1
Unexpected Therapeutic Results
1
1
Electro-Static Discharge
1
1
Suction Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
360
360
No Known Impact Or Consequence To Patient
69
69
No Consequences Or Impact To Patient
46
46
Insufficient Information
46
46
Laceration(s)
28
28
Injury
26
26
Fall
19
19
Bone Fracture(s)
16
16
Electric Shock
11
11
Abrasion
9
9
Pain
7
7
No Information
7
7
Limb Fracture
6
6
Unspecified Tissue Injury
6
6
No Code Available
5
5
Crushing Injury
5
5
Death
5
5
Bruise/Contusion
5
5
Burn(s)
5
5
Head Injury
5
5
Hematoma
3
3
Hyperextension
3
3
No Patient Involvement
3
3
Localized Skin Lesion
3
3
Low Blood Pressure/ Hypotension
2
2
Tooth Fracture
2
2
Skin Tears
2
2
Ulcer
2
2
Discomfort
2
2
Unspecified Musculoskeletal problem
2
2
Multiple Fractures
2
2
Cardiac Arrest
2
2
Muscle Weakness
2
2
Nausea
2
2
Nerve Damage
2
2
Edema
1
1
Tissue Damage
1
1
Hemorrhage/Bleeding
1
1
Device Embedded In Tissue or Plaque
1
1
Patient Problem/Medical Problem
1
1
Hematuria
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Getinge Group Logistics America, LLC
II
Mar-23-2021
2
Getinge Usa Sales Inc
II
Oct-04-2023
3
Getinge Usa Sales Inc
II
Nov-15-2022
4
IHB OPERATIONS B.V.
II
Dec-01-2023
5
Maquet Cardiovascular Us Sales, Llc
II
Oct-20-2020
6
Skytron, Div. The KMW Group, Inc
II
Jun-30-2022
7
Skytron, Div. The KMW Group, Inc
II
Jun-15-2021
8
Skytron, Div. The KMW Group, Inc
II
Mar-25-2020
9
Stryker Communications
II
Mar-24-2021
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