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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device table, operating-room, ac-powered
Product CodeFQO
Regulation Number 878.4960
Device Class 1


Premarket Reviews
ManufacturerDecision
MOON SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 104 104
2019 118 118
2020 97 97
2021 102 102
2022 125 125
2023 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 132 132
Use of Device Problem 47 47
Detachment of Device or Device Component 44 44
Insufficient Information 40 40
Improper or Incorrect Procedure or Method 33 33
Mechanical Problem 33 33
Adverse Event Without Identified Device or Use Problem 27 27
Electromagnetic Interference 23 23
Smoking 22 22
Unintended System Motion 19 19
Device Tipped Over 18 18
Break 15 15
Positioning Problem 15 15
Fluid/Blood Leak 14 14
Device Fell 13 13
Loose or Intermittent Connection 9 9
Device Emits Odor 9 9
Self-Activation or Keying 9 9
Device Slipped 9 9
Device Handling Problem 8 8
Noise, Audible 8 8
Sparking 7 7
Fire 7 7
Electrical /Electronic Property Problem 7 7
Complete Loss of Power 6 6
Physical Resistance/Sticking 6 6
Electrical Shorting 6 6
Therapeutic or Diagnostic Output Failure 5 5
Component Falling 5 5
Battery Problem 5 5
Device Operates Differently Than Expected 5 5
Failure to Read Input Signal 5 5
Communication or Transmission Problem 4 4
Defective Device 4 4
Circuit Failure 4 4
Positioning Failure 4 4
Disconnection 4 4
Key or Button Unresponsive/not Working 4 4
Patient Device Interaction Problem 4 4
Protective Measures Problem 4 4
Mechanical Jam 4 4
Operating System Becomes Nonfunctional 3 3
Material Split, Cut or Torn 3 3
Sharp Edges 3 3
Unintended Electrical Shock 3 3
Collapse 3 3
Detachment Of Device Component 3 3
Material Fragmentation 3 3
Leak/Splash 3 3
Device Sensing Problem 3 3
Device Inoperable 3 3
Unstable 3 3
Overheating of Device 2 2
Loss of Power 2 2
Device Difficult to Setup or Prepare 2 2
Connection Problem 2 2
Structural Problem 2 2
Device Displays Incorrect Message 2 2
Degraded 2 2
Unintended Collision 2 2
Material Disintegration 2 2
Thermal Decomposition of Device 2 2
Failure to Charge 2 2
Premature Discharge of Battery 2 2
Output Problem 2 2
Power Problem 2 2
Fail-Safe Problem 2 2
Device Dislodged or Dislocated 2 2
Inadequate User Interface 2 2
Patient-Device Incompatibility 2 2
Material Twisted/Bent 2 2
Installation-Related Problem 1 1
Electrical Overstress 1 1
Human-Device Interface Problem 1 1
Naturally Worn 1 1
No Flow 1 1
Physical Property Issue 1 1
Unexpected Shutdown 1 1
Intermittent Communication Failure 1 1
Separation Problem 1 1
Misassembly During Maintenance/Repair 1 1
Temperature Problem 1 1
No Apparent Adverse Event 1 1
Device Alarm System 1 1
Computer Software Problem 1 1
Failure to Conduct 1 1
Intermittent Continuity 1 1
Crack 1 1
Decrease in Suction 1 1
No Display/Image 1 1
Unintended Ejection 1 1
Device Maintenance Issue 1 1
Melted 1 1
Migration or Expulsion of Device 1 1
Moisture Damage 1 1
Labelling, Instructions for Use or Training Problem 1 1
Kinked 1 1
Flaked 1 1
Fracture 1 1
Calibration Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 195 195
No Known Impact Or Consequence To Patient 123 123
No Consequences Or Impact To Patient 64 64
Insufficient Information 33 33
Injury 32 32
Fall 24 24
Laceration(s) 20 20
Bone Fracture(s) 17 17
Electric Shock 12 12
No Information 12 12
No Code Available 10 10
No Patient Involvement 7 7
Abrasion 7 7
Head Injury 6 6
Pain 6 6
Crushing Injury 5 5
Death 5 5
Unspecified Tissue Injury 4 4
Burn(s) 3 3
Pressure Sores 3 3
Low Blood Pressure/ Hypotension 2 2
Discomfort 2 2
Skin Tears 2 2
Hyperextension 2 2
Unspecified Musculoskeletal problem 2 2
Cardiac Arrest 2 2
Bruise/Contusion 2 2
Muscle Weakness 2 2
Nausea 2 2
Nerve Damage 2 2
Edema 1 1
Tissue Damage 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Patient Problem/Medical Problem 1 1
Device Embedded In Tissue or Plaque 1 1
Hematuria 1 1
Physical Entrapment 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Deerfield Imaging, Inc. II Dec-20-2018
2 Deerfield Imaging, Inc. II Mar-28-2018
3 Deerfield Imaging, Inc. II Mar-27-2018
4 Deerfield Imaging, Inc. II Mar-13-2018
5 Getinge Group Logistics America, LLC II Mar-23-2021
6 Getinge Usa Sales Inc II Nov-15-2022
7 Maquet Cardiovascular Us Sales, Llc II Oct-20-2020
8 Skytron, Div. The KMW Group, Inc II Jun-30-2022
9 Skytron, Div. The KMW Group, Inc II Jun-15-2021
10 Skytron, Div. The KMW Group, Inc II Mar-25-2020
11 Stryker Communications II Mar-24-2021
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